<--- Back to Details
First PageDocument Content
Pharmaceutical sciences / New Drug Application / Premarket approval / Federal Food /  Drug /  and Cosmetic Act / Center for Devices and Radiological Health / Biologic License Application / Investigational New Drug / Title 21 of the Code of Federal Regulations / Investigational Device Exemption / Food and Drug Administration / Medicine / Health
Pharmaceutical sciences
New Drug Application
Premarket approval
Federal Food
Drug
and Cosmetic Act
Center for Devices and Radiological Health
Biologic License Application
Investigational New Drug
Title 21 of the Code of Federal Regulations
Investigational Device Exemption
Food and Drug Administration
Medicine
Health

Guidance for Industry and FDA Staff:

Add to Reading List

Source URL: www.fda.gov.

Download Document from Source Website

File Size: 101,18 KB

Share Document on Facebook

Similar Documents

Food and Drug Administration / Food safety / Food law / Adulteration / Generally recognized as safe / Federal Food /  Drug /  and Cosmetic Act / Center for Food Safety and Applied Nutrition / Premarket approval / Dietary supplement / Food and drink / Health / Safety

Microsoft PowerPoint - ditto

DocID: 1gc7K - View Document

Food and Drug Administration / Food safety / Food law / Adulteration / Generally recognized as safe / Federal Food /  Drug /  and Cosmetic Act / Center for Food Safety and Applied Nutrition / Premarket approval / Dietary supplement / Food and drink / Health / Safety

Microsoft PowerPoint - ditto

DocID: 1g6Me - View Document

Technology / Pharmaceutical industry / Clinical research / Food law / Pharmaceuticals policy / Premarket approval / Medical device / Federal Food /  Drug /  and Cosmetic Act / Validation / Food and Drug Administration / Medicine / Health

Federal Register / Vol. 80, NoWednesday, May 6, Notices Submit electronic comments on the draft guidance to http:// www.regulations.gov. Submit written comments to the Division of Dockets Management (HFA–

DocID: 1aGhA - View Document

Technology / Medical device / Premarket approval / Validation / Direct-to-consumer advertising / Federal Food /  Drug /  and Cosmetic Act / Title 21 CFR Part 11 / Structured Product Labeling / Medicine / Food and Drug Administration / Health

This document is scheduled to be published in the Federal Register onand available online at http://federalregister.gov/a, and on FDsys.govP DEPARTMENT OF HEALTH AND HUMAN SERVICES

DocID: 1akUI - View Document

Pharmacology / Pharmaceutical sciences / Pharmaceutical industry / Clinical pharmacology / United States Public Health Service / Medical device / Expanded access / Premarket approval / Investigational Device Exemption / Medicine / Food and Drug Administration / Health

CLEAN version with no appendices

DocID: 1ahmv - View Document