CDER News

This RSS news feed will end May 29 (Friday) due to changes in the FDA web site.

Providing Regulatory Submissions in Electronic Format--Drug Establishment Registration and Drug Listing

Providing Regulatory Submissions in Electronic Format--Drug Establishment Registration and Drug Listing

Guidance for Industry: Presenting Risk Information in Prescription Drug and Medical Device Promotion

Agenda for the May 27 - 28, 2009 Opioid REMS Public Meeting

Review and Conduct of Human Subject Research

Formal Meetings Between the FDA and Sponsors or Applicants

Drug Safety Oversight Board Meetings: Public Summaries, April 16, 2009

Labeling OTC Human Drug Products; Small Entity Compliance Guide

The Dear Colleague Letter, in anticipation of FY 2010 Invoices, was mailed Tuesday, May 5, 2009