As part of the Accelerating Rare disease Cures (ARC) Program, CDER’s Rare Diseases Team inaugurated the Learning and Education to Advance and Empower Rare Disease Drug Developers (LEADER 3D) initiative. Learn more.
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CDER Data Standards Program
CDER Data Standards ProgramNew Hoque & Sons Inc Issues Alert on Uneviscerated “Dry Ghoinnya Fish”
New Hoque & Sons Inc. of Maspeth, NY, is recalling its packages of “Dry Ghoinnya Fish” because the product was found to be uneviscerated.The recalled “Dry Ghoinnya Fish” were distributed nationwide in retail stores. The product comes in a 10-12 pound, clear plastic package marked with an expiratiImmacule Lifesciences Private Limited – 09/18/2025
Immacule Lifesciences Private Limited – 09/18/2025. Country: India. Record Type: 483Examples of Accepted Emerging Technologies
CDER’s Office of Pharmaceutical Quality created the Emerging Technology Program to promote the adoption of innovative approaches to pharmaceutical product design and manufacturing.E6(R3) Good Clinical Practice (GCP)
The Food and Drug Administration is announcing the availability of a final guidance for industry entitled “E6(R3) Good Clinical Practice.” This revision incorporates flexible, risk-based approaches and embraces innovations in trial design, conduct, and technology.The Ambriola Company Issues Recall of Cheese Products Because of Listeria Health Risk
The Ambriola Company is recalling select cheese products after routine testing confirmed the presence of Listeria monocytogenes, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Although healthy in