News

Article

FDA Q11 Draft Guidance Available for Comment

Author(s):

FDA issued a draft guidance, entitled "Q11 Development and Manufacture of Drug Substances," which is now available for comment according to a notice published on June 29, 2011, in the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.

FDA issued a draft guidance, entitled “Q11 Development and Manufacture of Drug Substances,” which is now available for comment according to a notice published on June 29, 2011, in the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 The draft guidance was developed in conjunction with the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use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 The draft guidance is intended to harmonize the scientific and technical principles relating to the description and justification of the development and manufacturing process of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

Newsletter

Get the essential updates shaping the future of pharma manufacturing and compliance—subscribe today to Pharmaceutical Technology and never miss a breakthrough.

Related Videos
A global supply chain map, visualizing the complex network of transportation routes and distribution centers | Image Credit: © venusvi - stock.adobe.com
Shortcut from point A to point B | Image Credit: © Olivier Le Moal - stock.adobe.com
Behind the Headlines, Episode 21: Waters-BD Merger, Merck’s $10B Bet, and Biotech’s Investment Frontiers
Wooden blocks spelling TARIFFS are placed on a map of North America, specifically over the United States and Mexico | Image Credit: © Rokas - stock.adobe.com
Jason Waite, International Trade Expert, Alston & Bird
Simona Guidi, Associate Director, ProPharma
Tore Bergsteiner
Behind the Headlines, Episode 20: CAR-T Milestones, Abbvie and Eli Lilly M&A Moves, and More