Overview Of The Fda Product-Specific Guidance Program

Overview of the FDA Product-Specific Guidance Program

U.S. Food and Drug Administration

Product-Specific Guidance Fundamentals from a Clinical Perspective

U.S. Food and Drug Administration

Product Specific Guidances Webinar – Opening Remarks

U.S. Food and Drug Administration

Product-Specific Guidances for Complex Generic Drugs

U.S. Food and Drug Administration

Product Specific Guidances (PSGs) (3of16) Generic Drugs Forum 2020

U.S. Food and Drug Administration

Pre-ANDA Program Overview (2of39) Complex Generics 2018

U.S. Food and Drug Administration

Pre-ANDA Interactions with the FDA (6of16) Generic Drugs Forum 2020

U.S. Food and Drug Administration

SBIA Program Overview - REdI 2020

U.S. Food and Drug Administration

Introduction to Regulatory Science at the FDA

OTC Monograph Reform Overview of Draft Guidance for Formal Meetings

U.S. Food and Drug Administration

FDA Guidance on Conduct of Clinical Trials of Medical Products During the Public Health Emergency

U.S. Food and Drug Administration

Facilitating Generic Drug Product Development through Product-Specific Guidances

U.S. Food and Drug Administration

FDA Webinar on the Infant Formula Transition Plan for Exercise of Enforcement Discretion (Part 1)

U.S. Food and Drug Administration

Model Informed Drug Development Approaches for Immunogenicity Assessments Workshop

U.S. Food and Drug Administration

FDA Fish and Fishery Products and Hazards Controls Guidance, 4th Edition: Introduction and Overview

U.S. Food and Drug Administration

FDA Webinar on New Infant Formula Transition Plan (Part 2)

U.S. Food and Drug Administration

FDA’s Clinical Regulatory Perspective: Designing First-In-Human Trial for Cellular and Gene Therapy

U.S. Food and Drug Administration

Panel Discussion on Product-Specific Guidances

U.S. Food and Drug Administration

FDA Webinar on the Infant Formula Food Ingredients Requirements

U.S. Food and Drug Administration

FDA Webinar on the Guidance for Industry on Infant Formula Enforcement Discretion Policy

U.S. Food and Drug Administration