Columns | View from Washington

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.