December 5, 2025
Share on Pinterest Doctors are raising concerns that the move to delay the hepatitis B shot for newborns upends decades of vaccination policy without evidence and […]
December 5, 2025
Reports Mandated by FDORA The Food and Drug Omnibus Reform Act of 2022 (FDORA) requires FDA to develop several different kinds of informational documents, including public […]
December 4, 2025
Share on PinterestA nationwide recall of shredded cheese products that may contain metal fragments raises concern over the possible risks of intestinal injury or illness. Luciano […]
December 4, 2025
On December 4, 2025, the Food and Drug Administration approved lisocabtagene maraleucel (Breyanzi, Juno Therapeutics, Inc., a Bristol-Myers Squibb Company) for adults with relapsed or refractory […]
December 4, 2025
HOW TO USE THIS SNAPSHOT The information provided in Snapshots highlights who participated in the key clinical trials that supported the original FDA approval of this […]
December 3, 2025
Share on PinterestThe risk of “scromiting” increases with chronic cannabis use, especially daily use. Maskot/Getty Images A vomiting disorder linked to chronic cannabis use, known colloquially […]
December 3, 2025
On December 3, 2025, the Food and Drug Administration granted traditional approval to pirtobrutinib (Jaypirca, Eli Lilly and Company) for adults with relapsed or refractory chronic […]
December 3, 2025
Reference: 21 CFR 361.1(c)(1) A Radioactive Drug Research Committee (RDRC) must consist of at least five individuals A physician recognized as a specialist in nuclear medicine [§ […]
December 3, 2025
Reference: 21 CFR 361.1(d)(1)-(d)(9) The RDRC is responsible for determining whether or not the proposed research study constitutes basic research and if so, whether the following […]
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