Manufacturers of compendial drug products approved under a new drug application or in an abbreviated NDA may submit an analysis from a properly qualified component supplier to prove the required level of control of residual solvents in the finished product, an FDA final guidance says. The 1guidance notes FDA requires U.S.-marketed drug products with a U.S. Pharmacopoeia monograph to meet the requirements for control of residual solvents described in USP General Chapter 467. The guidance might still create a hurdle for approval of some generics, many of which were held up by FDA's initial interpretation of the revised USP standards last year. Under the final guidance, non-compendial products must follow an International Conference on Harmonization guideline - Q3C Impurities: Residual Solvents. Differences between the ICH requirement and USP's could be an issue for firms seeking to launch an ANDA product quickly
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Advanz Pharma would have had to show that the European Commission’s decision to revoke Ocaliva’s conditional marketing approval risked causing serious and irreparable harm, according to lawyers from Van Bael & Bellis.
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