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The CDER Office of Generic Drugs publishes a MAPP to help assessors use the four-part harmony approach in OGD-related communicatio...[ Price : $8.95]
Alkermes announces that its investigational once-daily therapy alixorexton significantly improved wakefulness and reduced daytime ...[ Price : $8.95]
A MAHA Summit on 11/19 will hear from vice president JD Vance, HHS secretary Robert F. Kennedy, Jr., and FDA commissioner Marty Ma...[ Price : $8.95]
A biotechnology company specializing in adult-derived stem cells urges FDA to relax federal regulation of some regenerative therap...[ Price : $8.95]
FDA joins the United States Pharmacopeia and the Association for Accessible Medicines next month for a public workshop focused on ...[ Price : $8.95]
Orrick attorneys say discussions at an FDA Digital Health Advisory Committee meeting indicate the agency intends to adopt oversigh...[ Price : $8.95]
FDA approves Promegas OncoMate MSI Dx Analysis System as a companion diagnostic for identifying endometrial carcinoma patients who...[ Price : $8.95]
FDA introduces a new regulatory framework the plausible mechanism pathway designed to speed approval of highly personalized ther...