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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A new pilot aims to take Brazil closer to ‘digital transformation.’
The European Medicines Agency’s chief medical officer Steffen Thistrup argued that patients are able to understand the “complex regulatory and scientific issues” that the EMA committees discuss when they assess drugs.
Monitoring the use of decentralized elements in clinical trials is a priority for the European medicines regulatory network.
Pfizer told the Pink Sheet it would work with the health technology assessment institute, NICE, with the hope of making Hympavzi available to patients with hemophilia A via the National Health Service.
