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In comments to the European Medicines Agency, leading drugmakers requested more clarification, simpler language and various other revisions for the International Conference on Harmonisation’s draft addendum to its E9 guidelines. Read More
Sponsors conducting clinical trials using imaging-based primary endpoints should consider the choice of modality — such as echocardiography or single-photon emission computed tomography — as well as centralized image interpretation and how often image evaluations should be performed, according to final guidance from the FDA. Read More
Baroness Annabel MacNicoll Goldie of the UK’s House of Lords gave “the strongest possible reassurance” that if the EU clinical trials regulations are implemented in March 2020, they will apply to the UK. Read More
The UK government aims to stay up-to-date with EU changes for clinical trial procedures amid uncertainties over next March’s implementation of Brexit. Read More
The FDA’s Arthritis and Drug Safety Committee and the Risk Management Advisory Committee voted 15 to 5, with a single abstention, that Pfizer’s PRECISION trial, which compared Celebrex (celecoxib) to ibuprofen and naproxen, demonstrated comparable cardiovascular safety. Read More
The FDA issued final guidance on electronic submissions of drug master files, giving sponsors of Type III DMFs for packaging materials an extra year before submission requirements kick in. Read More