Blogs

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.

Craig Lipset, Co-Chair of DTRA, discusses the evolving nature of decentralized clinical trials and DTRA’s initiatives.

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

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.

Mary Costello, Head of Site and Investigator Networks at Medable, and Stephanie Abbott, Clinical Research Director at Western Washington Medical Group, discuss the changing landscape of decentralized clinical trials.

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

The European Union has at last agreed on how HTA should be coordinated among Europe's multiple HTA agencies, bringing to an end a three-year process of discussion.

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

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.

European authorities have announced a proposal for a framework to support not-for-profit organizations and academia in repurposing authorized medicines.

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

The main themes discussed at DPHARM 2021.

Dave Hanaman, Co-founder of Curavit, discusses his perspectives on decentralized clinical trials.

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

A new straw has appeared in the wind that may mean something more substantial will emerge than the customary rhetoric...

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.

A proposal to address inequities in access to critical COVID vaccine commodities is still deadlocked a year after it was submitted.

Vanessa Tassell, Vice President of Clinical Operations at Mirati Therapeutics, will discuss how some enterprises are navigating trials by incorporating strategies to expand clinical trial access to patients who need it.

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

The priority is to save lives, not be acknowledged.

The EU is offering some $13 million for advice on bringing to the market medicines that combat antimicrobial resistance—and there's only one month to claim the grant...and then nine to do the work.

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

Dr. MaryAnne Rizk, Medable’s Chief Strategy Officer, discusses why sponsors are embracing the decentralized model more often and how it's solving issues like accessibility and diversity.

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.