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Researchers say a hybrid pilot mock drug GMP inspection found that on-site investigators were able to interact with remote partici...[ Price : $8.95]
FDA withdraws its membership in the 32-member medical device Global Harmonization Working Party after failing to persuade the orga...[ Price : $8.95]
Federal Register notice: FDA sends to OMB an information collection extension entitled Good Laboratory Practice Requirements for N...[ Price : $8.95]
Unomedical recalls certain VariSoft Infusion Sets due to the risk that the devices connector may detach from the set.[ Price : $8.95]
FDA accepts for priority review an Abeona Therapeutics BLA for pz-cel (prademagene zamikeracel) for treating patients with recessi...[ Price : $8.95]
Federal Register notice: FDA makes available a final guidance entitled Covid-19: Developing Drugs and Biological Products for Trea...[ Price : $8.95]
FDA sends Aldeyra Therapeutics a complete response letter on its NDA for reproxalap, an investigational drug candidate for treatin...[ Price : $8.95]
Novartis recalls two lots of its Sandimmune oral solution (cyclosporine) 100 mg/mL due to crystal formation observed in some bottl...