FDA Q11 Draft Guidance Available for Comment - - BioPharm International

ADVERTISEMENT

FDA Q11 Draft Guidance Available for Comment


BioPharm Bulletin

FDA issued a draft guidance, entitled “Q11 Development and Manufacture of Drug Substances,” which is now available for comment according to a notice published on June 29, 2011, in the Federal Register. The draft guidance was developed in conjunction with the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH), and describes approaches to developing process and drug substance understanding. It also provides guidance on what information should be provided in certain sections of the Common Technical Document (CTD).

The draft guidance is intended to harmonize the scientific and technical principles relating to the description and justification of the development and manufacturing process of drug substances (both small molecules and biologics).

Comments on the guidance should be submitted before September 1, 2011. They can be submitted electronically to http://www.regulations.gov, or in writing to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

blog comments powered by Disqus

ADVERTISEMENT

ADVERTISEMENT

New Tax Rules May Deter Future Pharma M&A
October 1, 2014
NIH Seeks to Improve Vaccine Response with New Adjuvants
September 30, 2014
New Report Details Players and Pipelines in the Biosimilar Space
September 30, 2014
Baxter International Plans to Open R&D Center for Baxalta
September 30, 2014
FDA Releases First-Ever Purple Book for Biosimilar Characterization
September 26, 2014
Author Guidelines
Source: BioPharm Bulletin,
Click here