Columns | View from Washington

Agency will be reorganizing field force and compliance functions.

Agency seeks added resources and new approaches to accelerate more of these promising treatments to the market.

The Supreme Court’s emergency action maintaining access to mifepristone fails to protect agency from future rulings that could subvert drug approval process.

Legal experts: Ruling on abortion pill could spur challenges involving other authorized medical products.

Impact areas that will be closely watched during phase-out include drug testing and authorization, telehealth, and patient access.

The key issues for industry and FDA as the Orphan Drug Act hits its 40th anniversary.

Report by the Government Accountability Office calls for ramped-up oversight by FDA of institutional review boards.

Probe targets agency’s role in advising on drug testing and submissions.

With industry’s uneven track record in patient representation, sponsors now mandated to submit Diversity Action Plans (DAPs) to FDA for Phase III and pivotal studies.

Proposed realignment of the Office of Regulatory Affairs would impact oversight of drugs and medical devices as well.

Face-to-face meetings will now include in-person and virtual components.

Agency panel backs the use of a common bivalent shot for all patients.

House report on Aduhelm approval calls for FDA to clarify its role in advising sponsors on drug testing and submissions.

The Consolidated Appropriations Act for 2023 includes dozens of measures involving drug development and regulation.

Looking back on major FDA moves in 2022.

Following closely contested election, approval of FDA bills most likely tabled until new year.

Potential drug removal spotlights latest debate over the expedited pathway.

CBER maps modernization plan to handle surge in research and applications.

The ‘skinny’ user fee reauthorization tables multiple high-profile proposals.

Agency releases a series of new guidances to advance the reliability of patient-focused tools and methods.

Seek pared-down measure in funding bill to avert shutdown.

Agency officials express associated concerns around clinical trial data reliability and quality.

Administration launches national manufacturing initiative, with aim to reduce US reliance on biomedicine from China and other regions.

In countdown to renewal deadline, agency already feeling the effects of still-unclear legislative fate.

Pharma loses battle to block price negotiations, but implementation faces many challenges.

Better clinical data needed, as well as strategies for tackling opioid abuse, tobacco use, and food safety.

Citing strong reporting results, hybrid model to continue supplementing on-site inspections.

With debate swirling around products cleared through this pathway, reforms and tighter oversight likely.

With the renewal deadline looming—and disagreement still swirling on enhancing FDA authority—a counter proposal calls for a streamlined, fee-only bill.

Amid push to include this population more in clinical trials, the goal is to uncover improved evidence on the risks/benefits of drugs for these patients.

Agency leaders seek to build public trust in science and gain support for regulation.

Measure tackles infant formula, cosmetics, and diagnostics—plus drug development and access.

ICH draft guidance proposes standardized framework for identifying ways development programs for adult treatments can inform pediatric studies.

Plan to keep new methods adopted during COVID in place.

Medical device user-fees agreement, Aduhelm approval and access among issues in crosshairs.

Dual efforts focused on more inclusive research and more diverse enrollment in pre- and post-approval studies.

Transition likely with looming end to emergency use authorizations tied to COVID-19 pandemic.

Program looks to establish framework for agency and purchasers to “objectively rate” manufacturing sites.

Congressional bills put focus on comparator-drug access, more accurate trial and R&D cost determinations.

Several legislative initiatives on table that would extend agency’s reach

IP claims under microscope amid arguments over R&D policy and investment.

Measures being mulled to reform the AA process and address public concerns around its risk-benefit payoff.

Quality metrics, more domestic production aim to avoid supply disruptions and drug shortages.

The US Congress approved a federal spending package that increases funding for a range of programs to advance health and medicine.

From supply-chain and clinical-trial disruptions in Ukraine and Russia, to decisions to halt investment or maintain operations, global implications for industry and pharmaceutical production are immense.

Agency clarifies stance on applications for ‘me-too’ drugs not supported by multiregional trials.

Pressurized political, COVID climates greet his return to top spot.

Agency restarts more routine site visits amid slowdown of new COVID infections.

Political issues delay Senate confirmation of Califf.

New package to clarify responsibilities for federal health agencies.

Uncertainty over experimental medicines calls for review of AA process.

International collaboration needed to address distribution hurdles.

In a highly unusual decision for a therapy approved by FDA, CMS has taken action to limit prescribing and use of Biogen’s new and controversial Alzheimer’s treatment Aduhelm.

New therapies were approved at a steady pace in 2021.

Pfizer’s Paxlovid has gained emergency use authorization at a time when the U.S. is being devastated by the spreading Omicron variant.

FDA has become embroiled in the debate over access to “chemical” or “medication” abortions through the prescribing and distribution of the abortifacient, mifepristone.

The Biden administration’s choice to lead FDA successfully navigated a Senate confirmation hearing on Dec. 14, setting the stage for full Senate approval early next year.

President Biden highlighted how current proposals for curbing outlays on pharmaceuticals will help protect patients’ health and save the government billions.

Lessons learned from COVID-19 vaccine development.

FDA scientists are working to advance gene and cellular therapies, with new guidances for manufacturers on appropriate testing of treatments to minimize risks to patients and fill data gaps.

Leading legislators have launched the campaign to enact a second version of the 21st Century Cures Act.

The White House has decided to nominate Robert Califf to take the reins of the regulatory agency once again.

The Democratic legislative proposal to authorize price negotiations on costly medicines covered by Medicare has drawn opposition from brand pharmaceutical and biotech companies.

House and Senate leaders may have reached a compromise on a plan for controlling prices on select prescription drugs, but the industry continues to object.

FDA seeks to address the hurdles for incorporating real world data into submissions, while addressing concerns about relevance and reliability.

FDA is expanding its Emerging Technology Program and providing more support for new drug applications that present advanced manufacturing technologies.

Rumor has it the White House will name cardiologist and research pro Robert Califf to the top FDA job, a position he held for nearly a year at the end of the Obama administration. But he may face opposition in the Senate.

New methods and policies necessitated by the global pandemic are slated to become permanent fixtures in FDA enforcement and regulatory programs.

Demand for more efficient development of medical products is prompting regulatory authorities to incorporate additional sources of information into research and approval processes.

Critics say FDA is either acting too fast and risking public safety—or too slow—mired in rules while ignoring important scientific findings.

Biosimilar approvals and the advance of biosimilar testing and production may lead to greater access to alternative therapies.

If the debate over vaccines for adults and the need for extra booster shots has been heated, FDA will face even more scrutiny over the safety and value of vaccinating children under age 12.

FDA’s Vaccines and Related Biological Products Advisory Committee announces its recommendations for the authorization of a third dose of the Pfizer/BioNTech Comirnaty vaccine.

Democrats failed to gain sufficient support this week to advance long-debated legislation to permit Medicare drug price negotiations.

FDA is launching a program to test the safety and suitability of novel inactive ingredients for use in new drugs and biologics.

White House officials recently announced a nearly $3 billion program to ramp up production of vaccines and their components to better serve patients in the U.S. and globally.

A report from the bipartisan Congressional Budget Office analyzes how drug pricing policies could reduce the number of new therapies coming to market.

FDA has revealed its plan for revising and renewing its fee program for drugs and biologics.

The first COVID-19 vaccine, Comirnaty, has received FDA approval. How will vaccination rates be effected?

While biopharma companies will pay more than $3 million to file an NDA or BLA application during fiscal year 2022, new fees for generic drugs will see modest or no increases and those for biosimilars may drop or hold even.

All eyes are watching closely to see how well Viatris and Biocon Biologics’ Semglee, approved by FDA on July 28, competes with Sanofi’s well-established, long-acting insulin analog, Lantus.

In response to continued criticism of FDA’s initiative to make promising new therapies available to seriously ill patients based on early clinical results, Richard Pazdur, director of FDA’s Oncology Center of Excellence, lashed out at the alarmists and urged continued support for this early access process.

FDA is on track this year to authorize a notable number of new molecular entities and important biotech therapies.

FDA acting commissioner Janet Woodcock has outlined FDA’s plan to “transition to standard operations” for U.S. inspections.

A broad White House proposal to advance competition in major U.S. industries features several measures intended to make medicines more affordable for patients.

FDA acting commissioner Janet Woodcock has bowed to pressure and called on the HHS’s Office of the Inspector General to examine the review process for Biogen’s Alzheimer’s disease treatment, Aduhelm.

The Center for Biologics Evaluation and Research’s top priority is to approve biologics license applications (BLAs) to address vaccine hesitancy, according to CBER director Peter Marks.

The latest draft supports the creation of the Biden administration’s proposed Advanced Research Projects Agency for Health to accelerate research on cures for cancer, diabetes, Alzheimer’s and more.

CDER launches an initiative to gain more efficient and transparent operations of its advisory panels. Jill Wechsler reports.

FDA’s approval of Biogen’s treatment for Alzheimer’s disease has raised questions about the agency’s accelerated approval process.

The Biden administration has rolled out a broad initiative to promote domestic production of critical materials, including medicines and their ingredients.

The Biden administration supports a notable increase in funding for public health and research as a lead priority for the coming year.

Biopharma companies’ efforts to promote “vaccine equity” and “dose sharing” also aim to limit challenges to international patent protections.

FDA recently published a final guidance for making post-approval manufacturing changes to drugs and biologics, the culmination of a long-running effort to facilitate improvements in medical product quality through the product life cycle.

FDA has responded to pressures for quick and reliable processes with multiple guidance documents and policy initiatives for updating the clinical research process.

FDA expects to conduct only a small portion of scheduled facility visits in 2021 due to continued limitations on travel imposed by the COVID-19 pandemic.

The drive for “vaccine equity” around the world is bolstering efforts to limit patent protections on innovative medicines and vaccines to combat the global pandemic.

Sponsors ignoring FDA requirements will now face stricter penalties.

White House’s summary of “topline” funding requests this month continues efforts to combat coronavirus pandemic and to restore the nation’s economic health.

FDA officials have taken the unusual step of issuing the closeout report (form 483) on its just-completed re-inspection of Emergent BioSolutions’ Baltimore manufacturing facility.

Just two weeks after instructing Johnson & Johnson to take over operations at Emergent BioSolution’s noncompliant Baltimore manufacturing operation, FDA has called a halt in production of vaccine drug substance and to quarantine all remaining product at the Bayview plant.

FDA is halting enforcement of a policy that limits prescribing and dispensing of Mifeprex (mifepristone), a widely used drug to induce a medical abortion in the very early stages of pregnancy.

FDA acting commissioner Janet Woodcock announced that Patrizia Cavazzoni will become the director of the Center for Drug Evaluation and Research (CDER), shifting from her role as acting director since last spring.

A picture of wide manufacturing violations appears in a recently disclosed FDA form 483 report on a site visit to Emergent’s Baltimore vaccine plant.

Updated programs supporting the development and review of prescription medicines are being readied for approval by federal agencies and ultimately by Congress

New American Jobs Plan set to be funded by corporate taxes will affect biopharma industry.

FDA is reviewing the record of its accelerated approval program following recent withdrawals of certain key indications for several leading cancer therapies, based on the failure of post-approval studies to document extended benefits of treatment.

Federal Trade Commission to launch a broad review of drug-company mergers.

Concerns mount among regulated industry stakeholders as White House stalls on naming FDA permanent commissioner.

With the cancellation of most field site visits last year due to the coronovirus pandemic, FDA now faces a serous backlog in inspections both in the US and abroad.

Vaccine manufacturers anticipate significant boosts in output in the coming weeks.

FDA issues a sharp warning letter rebuking AcelRx Pharmaceuticals for its ”glib and simplistic” messaging on painkiller Dsuvia.

Despite challenges and disruptions posed by the coronavirus pandemic this past year, FDA annual reports on drug regulatory programs and policies confirm successful efforts for meeting review time frames and updating policies and programs.

R&D on medical treatments lags notable success with vaccines.

The selection of a new FDA commissioner has become a contentious issue in Washington. Jill Wechsler reports.

With Democrats controlling Congress and the White House, expectations are high that policy makers will revise certain coverage and payment policies. Jill Wechsler reports.

The process of distributing millions of doses of new vaccines across the nation has been much less effective than anticipated.

Efforts by the Trump administration to limit FDA’s authority have rekindled calls for FDA to become an independent regulatory agency.

Applications put on hold as agency limits alternative oversight methods.

CDER's process for vetting and authorizing important new therapies remained strong and productive last year, despite the need to deal with COVID-19 related approvals and policies.

President-elect Biden has announced initiatives to combat the widening coronavirus pandemic including a 13-member COVID advisory board.

This week's much-anticipated meeting of FDA’s vaccine advisory committee will address critical issues related to the testing and approval of vaccines to prevent COVID-19 infection.

FDA has published updated Emergency Use Authorization (EUA) requirements for new coronovirus preventives.

Fears about overly accelerated development programs has heightened demands for wider access to information on study protocols, statistical analysis plans, and early results.

With hundreds of trials for potential coronavirus drugs in the works, concerns swirl around the emergence of conflicting data, useless results, and wasted efforts from multiple overlapping efforts.

New agency initiatives aim is to fully reflect the impact of treatment on patients representing a range of ages, ethnic backgrounds, and other demographic features

The agency's Oncology Center of Excellence continues to build on successes in bringing innovative cancer drugs to patients through accelerated development and speedy approval of breakthrough treatments.

Gains in FDA approval of new drugs and biologics last year are based on limited clinical trials and accelerated review programs.

A view of the notable policy strategies advanced in 2019 to boost drug development and review.

Additional policies for registering clinical studies in U.S. and Europe aim to expand access to research data and provide timely information for patients on promising, new treatments.

Regulatory enforcement actions, policy updates, and new guidelines show that ensuring the reliability of clinical data is an ongoing priority.

FDA and other regulators are responding with support for more flexible monitoring of clinical investigators and review of study records in order to limit study monitoring to certain situations.

Patient advocates debate whether FDA approval on small, early clinical studies is too fast-tracked for efficacy and safety, or too slow due to long review processes.

Researchers and sponsors are looking to use RWE information to help in trial design, product use, developing new therapies, and gaining market approval.

FDA leaders urge developers, researchers, and research sponsors to help promote policies and programs to streamline clinical research to develop new medical products at reduced costs.

FDA released four new draft guidances that seek to broaden criteria for identifying and enrolling patients in clinical trials in an effort to reduce time and cost of clinical research for biopharmaceuticals.

FDA officials provide more specific plans for streamlining and modernizing plans for assessing and regulating products for cutting-edge cellular and gene-based medical treatments.

New FDA guidances outlining recommended approaches for clinical testing methods and collecting research data, alongside with public workshops and meetings, accelerate reviews to speed new therapies to market.

FDA is joining with other federal health agencies and the biomedical community to advance science, regulatory policies, and reimbursement strategies to combat the need for new medicines for infectious diseases.

Jill Wechsler details the continued rise of incorporating the “patient experience” in drug development measures.

Jill Wechsler details the two chief reasons why clinical trial quality and efficiency has improved in recent years.

Now the challenge to FDA and to sponsors is to maintain the high level of support for research, discovery, and regulatory flexibility underpinning these gains, writes Jill Wechsler.

The agency is moving to smooth the pathways for orphan drugs, genetic therapies, and other scientific advances to yield more transformative medicines.

New legislation aims to expand regulatory acceptance of patient data from healthcare systems and observational studies.

The agency is encouraging drug companies to adopt innovative research methods and development tools-and showing more flexibility in approving therapies that have taken non-conventional paths.

With the new FDA commissioner officially in, the FDA begins the considerable task of implementing key "Cures" initiatives.

The rise of new drugs targeting rare disease ignites increased push for flexible R&D approaches and more collaboration on orphan drug designation and clinical trial design between global regulators.

The needed resources to implement "Cures" legislation makes it critical that user fee programs for drugs are reauthorized well before they expire on Sept. 30.

With a new administration in Washington, sponsors and regulators are weighing several initiatives that promise to reshape clinical research policies.

FDA and industry have agreed on a set of recommendations for revising the drug user fee program, which now sits before Congress as U.S. election nears.

The need to revise the design, performance and interpretation of clinical research to reflect changing methods and standards is drawing increased attention.

FDA's breakthrough drug initiative has proven successful to date, but challenges remain in addressing the expectations and patient concerns surrounding candidates in this program.

FDA's new commissioner advocates for a "learning healthcare system" and less-complex clinical trial models that tap efficiencies in study design and enrollment.

Agency is asking sponsors to propose demonstration projects that test the use of electronic health records and standards-based technology solutions. Ensuring trials assess new drugs in diverse patient populations is also a priority focus for FDA.

These three areas will be at center of drug development discussions in the year ahead.

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The "Cures" bill and PDUFA IV are the latest measures pushing for more systematic inclusion of patient views into drug development.

Agency concerned about how proposals in "Cures" bill will be crafted and implemented.

The productivity of the U.S. biomedical research enterprise is undergoing a broad re-examination.

Agency proposes new standards in hopes of capitalizing on 2014 surge in new drug approvals.

The promise is that customized delivery of injectible drugs and biologics will reduce toxicity, enhance individual response, facilitate the delivery of multiple drugs, minimize waste, and encourage patient adherence to prescribed treatment.

There's a mounting campaign to encourage biopharmaceutical companies to develop new therapies to treat drug-resistant infections.

The rush is on to develop new therapies and vaccines to combat the lethal outbreak.

The mounting outrage over exorbitant prices for new medicines increases the importance of reducing the cost of biomedical product development.

Congressional leaders have launched a major initiative to revise laws and regulatory policies to speed new cures to patients.

A national publicity campaign recently succeeded in obtaining early access to an experimental treatment for a seriously ill child, touching off a broader discussion of compassionate use policies and their impact on drug development and approval.

Despite guidances and rules advising sponsors to include all demographic groups in clinical trials, many subgroups remain underrepresented.

Pharmaceutical companies are jumping on the clinical trial transparency bandwagon, while also seeking to protect confidential information.

The decline in important new medicines reaching market in 2013 has produced multiple proposals for making clinical trials more effective and efficient.

The shift to personalized medicine has begun to account for a greater portion of new therapies in pharmaceutical pipelines, and the biomedical research community is watching to see if this trend continues in the coming months.

Ease of use, and clear directions and labeling can improve patient satisfaction with participating in a study and enhance compliance, says new ISPE survey.

Policies to widen access to patient level data from clinical trials are gaining traction, despite strong opposition from research sponsors that such initiatives will undermine patient privacy and incentives for new drug development.

Multiple proposals for streamlining research emerge in legislation, expert reports.

Expanding access to nonprescription drugs and facilitating comparative effectiveness research.

Demand for more information on study results and investigator payments create challenges.

Congress, industry map out goals and concerns for revising FDA policies linked to user fee legislation.

FDA wants sponsors to build quality into protocols, adopt risk-based strategies to streamline trials.

Pressure to approve new user fees will affect policies for foreign studies and research methods.

A comprehensive listing of US departments and offices that includes the telephone numbers of directors, commissioners, and advisors.

Alternative approaches aim to tackle drug shortages, spur orphan drug development.

Multiple regulatory and reimbursement proposals are slated to expand legislation to renew PDUFA.

Modernizing the Common Rule to update research policies could spell important changes.

Pharmaceutical testing and production overseas spurs call for more reliance on counterparts.

Debate narrows over extent of pre-clinical and clinical testing for follow-on versions of complex biologics.

CER funding boosts agency informatics initiatives that promise to modernize research and review processes

FDA, NIH, industry seek new strategies to support drug development, revive pharma pipeline.

Presidential panel to examine need for tighter rules governing US and foreign clinical trials.

FDA's Sentinel Initiative sets pace for tapping e-health records for product assessment.

Congress readies probes of FDA practices, while FDA seeks transparency and organizational changes.

New user fees, health initiatives, and FDA compliance concerns are top issues for 2011.

A comprehensive listing of US departments and offices that includes the telephone numbers of directors, commissioners, and advisors.

PCORI, methods panel to set policies for comparing drugs and medical products and practices.

Reform law requires tracking and disclosure of fees to investigators and research consultants.

Sponsors, health care providers weigh pros and cons of REMS for bringing risky products to market.

Inspector General study focuses attention on quality of data and patient safeguards.

More information may be available on drug applications to expand public understanding of FDA policies.

FDA eyes risk approaches to site inspections to use resources more efficiently.

Pharma will pay new fees and rebates but gain drug utilization and safeguards to innovation.

FDA Commissioner Hamburg seeks resources to build agency scientific expertise & new research methods.

FDA is modernizing systems to better access data on drug effects, utilization, and safety.

New commissioner seeks to expand FDA's capabilities to bring safe and effective drugs to patients.

Globalization and reform initiatives will take part in shaping biomedical research and clinical studies.

A comprehensive listing of U.S. departments and offices that includes the telephone numbers of directors, commissioners, and advisors.

FDA reviewers strive to assess new postmarketing programs while also evaluating applications.

Stiffer enforcement of research standards aims to restore the public's confidence in agency actions.

International health crises expand testing of new vaccines and drug treatments for third-world diseases.

Pressure to reduce health care spending puts R&D, costs, and coverage on the negotiating table.

FDA leaders stress innovation and disclosure in promoting the agency's public health mission.

Agency officials and sponsors anticipate stiffer oversight of research operations and disclosure requirements.

Government funding slated to boost studies comparing medications to other treatments.

Biomedical research community finds privacy policies add cost and complexity to clinical studies.

Reformers seek disclosure of investigator payments and conflicts of interest.

Proposals to reduce outlays for drugs could limit biomedical research and product development.

More resources and new leadership could help FDA regain its stature and bolster support for innovation.

A comprehensive listing of U.S. departments and offices that includes the telephone numbers of directors, commissioners, and advisors.

FDA is conducting more inspections to ensure that foreign clinical research meets GCP standards.

Global harmonization, regulatory flexibility promise to expand treatments for rare and neglected diseases.

Comparative drug analysis aims to address costs and value as candidates eye curbs on drug spending.

Ketek probe raises questions about research oversight by FDA, sponsors, and investigators.

FDA, NIH, and sponsors all struggle to implement complex registration and data access requirements.

The agency's 2008 budget fails to keep up with expanding programs, added safety concerns.

FDA and sponsors implement FDAAA as pressure builds to curb drug prices and tweak the R&D process.

Information systems and lax enforcement criticized as Congress expands trial disclosure requirements.

Expanded access to drugs for seniors has increased demand, focusing more attention on medical costs.

Journal editors and legislators expand the scope of clinical trial registration and results disclosure.

High-quality programs needed to protect subjects, improve data, harmonize global trials, and manage costs.

Added information to inform treatment decisions may drive up research costs for sponsors.

Policy makers discuss incentives for trials on children and for generic versions of biotech therapies.

Drug safety concerns, unproductive methods, and high costs encourage innovative study designs and collaborative efforts.

Regulators and sponsors encourage alternative review models to fit a growing research enterprise.

Shift in Congressional control opens door to probes into research practices & expansion of PDUFA legislation.

A changing research enterprise requires clearer policies and more effective regulatory tactics.

Under IOM's plan, a "lifecycle approach" to drug evaluation would change FDA's pre- and postapproval policies.

Confusion over policies governing prisoners points to the need for clear, uniform safeguards for all research.

Rise in foreign studies requires attention to ethical issues, investigator training.

Agency seeks to calm critics by improving subject protection, while also streamlining research oversight.

Payers seek more comparative drug data from sponsors and independent researchers.

The much anticipated list features initiatives in biomarkers and research productivity.

More consultations with sponsors promise to drive drug development, but also impose a growing burden on FDA.

FDA seeks to reduce clinical research failures and make drug labeling more useful.

Drug safety and R&D issues will play a prominent role in user fee program revisions.

Changes prompt new oversight approaches by FDA and research institutions.

While veteran officials keep the agency running, changes continue at FDA's new drug review and safety oversight offices.

A comprehensive listing of U.S. departments and offices that includes the telephone numbers of directors, commissioners, and advisors.

Curbs on consulting and financial interests aim to restore researchers' credibility.

Commissioner Crawford's challenge is to restore public confidence in drug safety and approvals.

Recent events highlight the need to clarify rules and policies for pediatric studies.

Regulators and researchers seek to curb the overload on IRBs and harmonize AER policies.

Clinical trials may take longer and become larger as proposals emerge to strengthen regulatory policies.

New policies aim to simplify testing for single-pill combos and products that combine drugs with medical devices.

Concerns over risky medicines are shutting down clinical studies and boosting demand for comparative drug analysis.

Inadequate pre-approval testing and information disclosure may slow new drug development and change regulations.

The Medicare drug benefit and FDA's Critical Path Initiative will push and pull new drug development.

FDA eyes new approaches to testing drugs for children and adults, and clarifies electronic data policies for clinical trials.

Sponsors react to pressure to register ongoing clinical trials and to provide access to drug studies.

FDA encourages clinical data e-submission and boosting development of new therapies to combat bioterrorism, cancer, and obesity.

New standards and research methods aim to provide more useful information on population subgroups.

FDA and NIH investigate staff relationships with industry to eliminate any outside influence on regulatory decisions and clinical trial procedures.