FDA Q11 Draft Guidance Available for Comment - - BioPharm International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FDA Q11 Draft Guidance Available for Comment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FDA issued a draft guidance, entitled “Q11 Development and Manufacture of Drug Substances,” which is now available for comment according to a notice published on June 29, 2011, in the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 The draft guidance was developed in conjunction with the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use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The draft guidance is intended to harmonize the scientific and technical principles relating to the description and justification of the development and manufacturing process of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

FDA Extends Review of Novartis' Investigational Compound for Multiple Myeloma
November 25, 2014
Merck Enters into Licensing Agreement with NewLink for Investigational Ebola Vaccine
November 25, 2014
AstraZeneca Expands Biologics Manufacturing in Maryland
November 25, 2014
GSK Leads Big Pharma in Making Its Medicines Accessible
November 24, 2014
IMS: Global Spending on Medicines to Rise 30% by 2018
November 24, 2014
Author Guidelines
Source: BioPharm Bulletin,
Click here