The Well News on MSNOpinion

Post-Prasad, FDA must embrace reform

At long last, the Food and Drug Administration's Center for Biologics Evaluation and Research Director Vinay Prasad is out.
PhillyVoiceOpinion

FDA's abrupt flip‑flop on Moderna's mRNA flu shot highlights growing risks to drugmakers of investing in vaccines

Incentives to bring vaccines to market are shrinking. Drugmakers are scaling back research investments and cutting jobs.
C&EN

March 13 Policy Watch: FDA streamlines its process for approving biosimilar drugs

In another development, 25 states have petitioned to join a lawsuit and defend the EPA’s decision to rescind the climate endangerment finding ...
Becker's ASC

FDA contemplates changing approval process for software used as a medical device — 4 insights

The FDA is contemplating changing its medical device for software approval process, JD Supra reports. Here’s what you should know. 1. Software as a medical device applies to all software used to ...
STAT

The FDA is circumventing key roles and procedures for licensure and use of Covid vaccines

The Food and Drug Administration’s recent activities regarding Covid-19 vaccines stray far from the well-established standards of vaccine regulatory processes. The first sign of trouble was the ...
JD Supra

Court gives new life to the post-CRL administrative hearing process, rules that FDA can deny hearing only when evidence is ‘conclusively deficient’

On August 15, 2025, the U.S. Court of Appeals for the D.C. Circuit limited FDA's ability to deny a hearing on the approvability of a new drug application (NDA) based on a lack of “substantial evidence ...
Opinion
Worcester Telegram on MSNOpinion

Opinion/Guest column: Fastest route to FDA approval not the best

The strength and credibility of the FDA relies on maintaining a clear line between evidence-based, scientific rigor and political priority setting.
JD Supra

FDA’s Rare Disease Evidence Principles Process Provides Guidance for Applications Supported by a Single Pivotal Trial

On September 3, 2025, the US Food and Drug Administration (FDA) announced a new process to support the development of drugs intended to treat rare genetic diseases. The Rare Disease Evidence ...
Becker's Hospital Review

New FDA office will update drug approval process

The FDA plans to establish the Office of Drug Evaluation Science to improve and modernize the review process for new medications, according to STAT. The new office will help develop a standardized ...
MobiHealthNews

How the FDA process is biased against new technology

As FDA itself observes, “devices of a new type that FDA has not previously classified … are ‘automatically’ or ‘statutorily’ classified into class III…, regardless of the level of risk they pose.” To ...
The Baltimore Sun

FDA announces sweeping changes to speed up the drug review process

The Food and Drug Administration has announced some major changes to the review process for drug developers in the United States. It could cut down the time from 10 to 12 months for a review to just ...
CSNews

FDA Updates Draft Guidance on Flavored Vapor Applications

SILVER SPRING, Md. — The U.S. Food and Drug Administration (FDA) released draft guidance on how it intends to evaluate ...