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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

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

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.

The Next Big COVID Challenge: Vaccines for Children Under 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.

Vaccine Booster Battle Reveals Rifts Among Regulators, Sponsors

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

Pharma Blocks Democrats’ Drug Pricing Plan

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

FDA Moves to Advance Innovative Excipients

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.

Biden Bolsters Vaccine Production in Pandemic Preparedness Plan

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

Will Price Controls Limit Drug Development? The Debate Heats Up. 

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

FDA, Industry Map New R&D Initiatives under Next User Fee Program

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