Articles

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.

Can Califf Bring Clarity and Enhanced Credibility to FDA?

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

Pandemic Alters FDA Inspections, Quality Oversight

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

FDA, Sponsors Advance Reliance on Real-World Data & Evidence

Peter O'Donnell is a freelance journalist who specializes in European health affairs and is based in Brussels, Belgium.

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

Sharing COVID Vaccine Know-How: A New Twist on a Long-Running Debate

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.

New Operational Methods Emerge in Cancer Clinical Trials

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

FDA Officials Caught in Political Crossfire

The priority is to save lives, not be acknowledged.

What Can We Learn from Data-Sharing During the COVID-19 Pandemic?

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.

Multi-million European Contracts Up for Grabs for Developing Antibiotics

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

Biosimilars Gain Traction with Regulators and Manufacturers

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. 

Blogs