Office of Prescription Drug Promotion (OPDP) Research
The Office of Prescription Drug Promotion (OPDP) has an active research program designed to investigate applied and theoretical issues of…
OPDP eCTD
The OPDP eCTD page contains all resources and reference materials produced by OPDP in support of the OPDP Electronic Submissions…
Shirish M. Gadgeel, M.D. – 716181 – 09/04/2025
Clinical Investigator
Hikal Limited – 709370 – 08/20/2025
CGMP/Active Pharmaceutical Ingredient (API)/Adulterated
Impurity Profiling of ATS Synthesized From Ring‐Substituted APAAN and MAPA Analogs
Arylacetonitriles, for example, where Ar = p-methoxyphenyl, have been converted into ketones and then ATS. Byproducts arising from this synthetic sequence have…
Safety Labeling Change Orders
Section 505(o)(4) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 355(o)(4)) authorizes FDA to require application…
Biosimilars Guidances
This page lists Biosimilars Guidance documents.
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.”…
FDA’s Sixth Online Controlled Substances Summit – 09/11/2025
FDA, in partnership with the Reagan-Udall Foundation, will host the sixth Online Controlled Substances Summit on September 11, 2025.
Classification Categories for Certain Supplements Under BsUFA III
Classification Categories for Certain Supplements Under BsUFA III