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The Food and Drug Administration plans to ask Sarepta Therapeutics Inc. to pause shipments of its Elevidys treatment after ...
For instance, "the backlog of FOIAs ... is enormous," he said. Califf said the FDA has far greater opportunities for improved ...
The FDA proposes to revoke standards for 18 dairy products, including low-sodium cheddar and colby cheese, acidified milk and ...
The trove of more than 200 letters is part of a pledge of transparency from the agency, with the intention to increase public ...
By disclosing the CRLs, the FDA provides an insight into common pitfalls that sponsors must rectify to gain approval.
The U.S. Food and Drug Administration on Thursday publicly shared over 200 archived so-called complete response letters ...
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 ...
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 ...
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… ...
"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 ...
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 ...