Preparation and Public Availability of Information Given to Advisory Committee Members: Guidance for Industry
Detailed guidance document from FDA and regulatory agencies.
Document Details
Guidance Document
August 1, 2008
April 21, 2019
7f43f696-9968-424a-adfe-f0d2b562e1d3
Related Documents
Prescription Drug Marketing Act (PDMA) Requirements- Questions and Answers
Guidance DocumentNovember 15, 2006Center for Drug Evaluation and Research
180-Day Exclusivity When Multiple ANDAs Are Submitted on the Same Day
Guidance DocumentJuly 1, 2003Center for Drug Evaluation and Research
Voting Procedures for Advisory Committee Meetings: Guidance for FDA Advisory Committee Members and FDA Staff
Guidance DocumentAugust 1, 2008Office of the Commissioner
Quick Actions
Transform Regulatory Data into Actionable Intelligence
Join leading pharmaceutical and medical device companies who trust KeyPedia for their regulatory compliance needs.