Performance & Innovation !
|
COMPETITIVE AND BUSINESS INTELLIGENCE
|
US FDA GUIDANCE DOCUMENTS
|
|
Final Rule: Food Labeling: Health Claims; Soluble Fiber from Certain Foods and Risk of Coronary Heart Disease (Barley Betafiber) Federal Register, August 15, 2008
The Nutrition Labeling and Education Act of 1990 (the 1990 amendments) (Public Law 101-535) amended the Federal Food, Drug, and Cosmetic Act (the act) in a number of important ways. One aspect of the 1990 amendments was that they clarified FDA's authority to regulate health claims on food labels and in food labeling. Full document...
Current Good Manufacturing Practice and Investigational New Drugs Intended for Use in Clinical Trials; Final Rule
This guidance document sets forth recommendations on approaches to compliance with statutory CGMP for the exempted phase 1 investigational drugs. Full document...
Guidance for Industry: CGMP for Phase 1 Investigational Drugs
This guidance is intended to assist in applying current good manufacturing practice (CGMP) required under section 501(a)(2)(B) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) in the manufacture of most investigational new drugs (IND) used in phase 1 clinical trials. Full document...
Guidance for Industry: Safety, Efficacy, and Pharmacokinetic Studies to Support Marketing of Immune Globulin Intravenous (Human) as Replacement Therapy for Primary Humoral Immunodeficiency
The document provides guidance on general principles concerning clinical trial design to evaluate safety, efficacy, and pharmacokinetics of investigational IGIV products and is intended to assist you in the preparation of the clinical/biostatistical and human pharmacokinetic sections of a BLA. Full document...
Guidance for Industry: Microbiological Considerations for Antimicrobial Food Additive Submissions
This guidance applies to all FAPs, FCNs and TOR requests where the food additive is intended to control microbes in or on food. Full document...
Guidance for Industry: Final Rule Declaring Dietary Supplements Containing Ephedrine Alkaloids Adulterated Because They Present an Unreasonable Risk (Small Entity Compliance Guide)
This guidance document restates in plain language the legal requirements set forth in 21 CFR 119.1 concerning dietary supplements containing ephedrine alkaloids. Full document...
ICH; Guidance for Industry: Q3A Impurities in New Drug Substances
This document is intended to provide guidance for registration applications on the content and qualification of impurities in new drug substances produced by chemical syntheses and not previously registered in a region or member state. Full document...
<<< 1 2 3 4 5 6 7 8 9 10 >>> |
|
| ONLINE STORE |
|
|
FREE FEEDBACK |
How often do you visit this site? |
|
WEB PARTNERS |
|
|
|
|
|
|
|
|
|
| |
| |
| |
| |
| |
|
