News

FDA to Ask Sarepta to Halt Elevidys Shipments After Deaths
The Food and Drug Administration plans to ask Sarepta Therapeutics Inc. to pause shipments of its Elevidys treatment after ...
Medpage Today on MSN1d
CRLs Are the Low-Hanging Fruit of FDA Transparency, Experts Say
For instance, "the backlog of FOIAs ... is enormous," he said. Califf said the FDA has far greater opportunities for improved ...
Dairy Reporter11h
FDA to ditch ‘obsolete’ food standards to boost transparency
The FDA proposes to revoke standards for 18 dairy products, including low-sodium cheddar and colby cheese, acidified milk and ...
BioSpace7d
FDA Publishes Cache of Complete Response Letters in Bid for ‘Radical Transparency’
The trove of more than 200 letters is part of a pledge of transparency from the agency, with the intention to increase public ...
Pharmaceutical Technology on MSN7d
FDA publishes more than 200 archived CRLs for transparency
By disclosing the CRLs, the FDA provides an insight into common pitfalls that sponsors must rectify to gain approval.
US FDA publishes 200 complete response letters from archive in transparency drive
The U.S. Food and Drug Administration on Thursday publicly shared over 200 archived so-called complete response letters ...
Eater3mon
The Next Foodborne Illness Outbreak Might Fly Under the Radar | Eater
The FDA has, in recent years, shifted toward “greater transparency” because letting people know that they might have bacteria-contaminated groceries in their refrigerator has multiple benefits ...
Retail TouchPoints5mon
Embracing MoCRA for a Safer, Transparent Cosmetics Industry
Under MoCRA, the FDA mandates rigorous facility registration and product listing requirements that impact cosmetic manufacturers globally. Some exemptions do apply. As of December 29, 2023, all ...
New York Post7mon
FDA must disclose more COVID-19 vaccine records, US judge rules
A federal judge has ordered the U.S. Food and Drug Administration to publicly disclose more information underpinning its authorization of COVID-19 vaccines, after failing to persuade the court to e… ...
Health Affairs9mon
Robust Evidence Synthesis To Support Transparent Medicare Drug Price ...
"Robust Evidence Synthesis To Support Transparent Medicare Drug Price Negotiation", Health Affairs Forefront, October 10, 2024 . DOI: 10.1377/forefront.20241009.659932 Caption. 1101 Connecticut ...
CNN2mon
In reversal, FDA rehires staff tasked with releasing public records
Lawyer Aaron Siri filed the FOIA lawsuits, on behalf of the nonprofit Public Health and Medical Professionals for Transparency, in 2021 and 2022 against the FDA to obtain records related to Pfizer ...