FDA introduces a new regulatory framework the plausible mechanism pathway designed to speed approval of highly personalized therapies for rare genet...
A biotechnology company specializing in adult-derived stem cells urges FDA to relax federal regulation of some regenerative therapies.
Orrick attorneys say discussions at an FDA Digital Health Advisory Committee meeting indicate the agency intends to adopt oversight of generative arti...
The CDER Office of Generic Drugs publishes a MAPP to help assessors use the four-part harmony approach in OGD-related communications to applicants.
FDA joins the United States Pharmacopeia and the Association for Accessible Medicines next month for a public workshop focused on how compendial stand...
A MAHA Summit on 11/19 will hear from vice president JD Vance, HHS secretary Robert F. Kennedy, Jr., and FDA commissioner Marty Makary, among many oth...
FDA approves Promegas OncoMate MSI Dx Analysis System as a companion diagnostic for identifying endometrial carcinoma patients who may benefit from tr...
Cumberland Pharmaceuticals asks FDA to ensure that labeling for generic Acetadote products includes information from the innovator labeling about a tw...
