All Topics
All Topics
Technology
Technology
AI
AI
Business
Business
Entertainment
Entertainment
News
News
Programming
Programming
Science
Science
Design
Design
Environment
Environment
Finance
Finance
Crypto
Crypto
Politics
Politics
Sports
Sports
Education
Education
Gaming
Gaming
Art
Art
Music
Music
Health
Health
Security
Security
Books
Books
Food
Food
Travel
Travel
Personal
Personal
Bluesky
Twitter

FDA halts release of new drug rejection letters while working to formalize policy

Darren Incorvaia13h agoen
Read on fiercebiotech.com

From the article

The FDA has paused a controversial policy of releasing letters describing its rationale for rejecting drugs, Fierce Biotech has learned, following a citizen’s petition from an unnamed pharma company in April.
Continue reading on Fierce Biotech

You might also wanna read

FDA Issues Refusal-to-File Letter to Moderna for mRNA Influenza Vaccine

The article criticizes the FDA's recent actions under the new administration, particularly focusing on a Refusal-to-File (RTF) letter issued

marginalrevolution.com·4mo ago

Researchers Call for FDA to Require Negative Drug Studies on Product Labels After Approval of Drug with Mostly Negative Results

Researchers argue that the FDA should require negative studies of new drugs to be included in product labeling, not just positive ones, to p

medpagetoday.com·10d ago

How excessive FDA manufacturing requirements are bottlenecking cell and gene therapy companies

The article argues that excessive FDA manufacturing requirements are crippling cell and gene therapy companies, using Grace Therapeutics as

writingruxandrabio.com·5d ago

Pharma CEOs' silence enables Trump administration's assault on U.S. biomedical research, argues Washington editor

The article argues that pharma CEOs are complicit in the destruction of U.S. science by remaining silent as the Trump administration, partic

biocentury.com·1mo ago

Replimune to resubmit melanoma drug for FDA approval after agency leadership changes

Replimune plans to resubmit its melanoma drug for FDA approval following a leadership shakeup at the agency. The drug was twice rejected und

cnbc.com·1mo ago

FDA Announces Plans to Restrict Non-Approved GLP-1 Drugs in Compounded Medications

The FDA is announcing its intent to take action against non-FDA-approved GLP-1 drugs, specifically targeting GLP-1 active pharmaceutical ing

fda.gov·5mo ago

Comments

Sign in to join the conversation.

No comments yet. Be the first.