The Association for Accessible Medicines asks FDA to clarify several issues from a draft guidance on instances when a generic drug company fails to re...
PhRMA uses a citizen petition to ask FDA and HHS to stop moving forward on their proposal to allow some drug importation from Canada.
Four stakeholder companies raise questions about an FDA draft guidance on using physiologically based pharmacokinetic analyses in oral drug product de...
The Association for the Advancement of Medical Instrumentation publishes consensus guidelines for implementing remote control for many critical medica...
Federal Register notice: FDA sends to OMB an information collection extension for Good Laboratory Practice for Nonclinical Laboratory Studies 21 CFR ...
Federal Register notice: FDA sends to OMB an information collection extension for Electronic Records; Electronic Signatures 21 CFR Part 11.
Federal Register notice: FDA reopens the comment period for a 5/31/2019 notice entitled Fixed-Quantity Unit-of-Use Blister Packaging for Certain Immed...
FDA warns dietary supplement manufacturer ForYou, Inc., about CGMP and other violations in its production and distribution of dietary supplements.