The quarterly submission deadlines for proposals to the Rare Disease Endpoint Advancement Pilot Program are March 31, June 30, September 30, and December 31.  Sponsors may […]

[6/14/2024] Today, FDA issued a proposed administrative order, to address a safety issue related to over-the-counter (OTC) monograph drug products containing acetaminophen. Based on a comprehensive […]

6/14/2024 La Paix contains hidden drug ingredient 1/30/2024 Arize contains hidden drug ingredient 1/30/2024 Schwinnng contains hidden drug ingredient 1/30/2024 Sustain® contains hidden drug ingredients 1/2/2024 […]

[6-14-2024] The Food and Drug Administration is advising consumers not to purchase or use La Paix, a product promoted and sold for sexual enhancement on various […]

[6-14-2024] The Food and Drug Administration is advising consumers not to purchase or use Umary, a product promoted and sold for pain on various websites, including https://www.solovital.com […]

Docket Number: FDA-2023-D-4067 Issued by: Guidance Issuing Office Center for Drug Evaluation and Research The Food and Drug Administration (FDA or Agency) is announcing the availability […]

Docket Number: FDA-2022-D-0235 Issued by: Guidance Issuing Office Center for Drug Evaluation and Research This guidance provides recommendations to assist industry in the development of oligonucleotide […]

What’s New FDA will begin accepting requests to participate in year two of the CDRP on October 2, 2023. Federal Register Notice What is the CDRP […]

Background The Federal Food, Drug, and Cosmetic Act (FD&C Act), section 524, authorizes FDA to award priority review vouchers (PRVs) to sponsors of approved tropical disease […]