FDA issued a draft guidance, entitled "Q11 Development and Manufacture of Drug Substances," which is now available for comment according to a notice published on June 29, 2011, in the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FDA issued a draft guidance, entitled “Q11 Development and Manufacture of Drug Substances,” which is now available for comment according to a notice published on June 29, 2011, in the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 The draft guidance was developed in conjunction with the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use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 The draft guidance is intended to harmonize the scientific and technical principles relating to the description and justification of the development and manufacturing process of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.
Prokaryotics Licenses Gram-Negative Antibiotic Potentiator from Northern Antibiotics
June 26th 2025Prokaryotics will gain worldwide rights to develop, manufacture, and commercialize NAB741, a non-bioactive polymyxin designed to increase permeability of the outer membrane of Gram-negative bacteria.