An Apotex Research facility in Bangalore, India was cited for non-compliance with GMP requirements after an inspection in November by the UK’s Medicines and Healthcare products Regulatory Agency revealed non-sterile…
The FDA received a wide range of comments and questions Monday at a public meeting to receive comments on a discussion document on patient-focused drug development — an early draft…
The European Medicines Agency adopted the International Council for Harmonisation’s E17 guideline on multi-region clinical trials, which can support simultaneous product submissions in different parts of the world and more…
CBER said it will prefer using internationally harmonized standards developed by third-party organizations — as opposed to maintaining its own — and it is urging sponsors of biologics to do…
The European Medicines Agency’s Committee for Medicinal Products for Human Use recommended seven new products for European Commission approval, including one biosimilar and two orphan medicines, one being an advanced…
The FDA released a draft guidance for the development of drugs that use nanomaterials, stating the importance of describing and analyzing nanomaterials and their attributes in a product’s finished form.…
New FDA draft guidance published last week breaks down the use of targeted therapies in low-frequency and rare molecular disease subsets. Source: Drug Industry Daily
The FDA outlined how it will use information requests and the newly established discipline review letter — which originates from specialized staff concerning their portion of an ANDA review, such…
In the coming year, the FDA’s top priorities will include broadening non-prescription access to drugs and updating compounder regulations, according to Commissioner Scott Gottlieb. Source: Drug Industry Daily
A federal judge threw out a case against GlaxoSmithKline that was part of multidistrict litigation over the labeling of its diabetes drug Avandia. Source: Drug Industry Daily