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Sidley Austin attorneys pull five takeaways, including challenges, from a recent FDA draft guidance on off-label communications be...[ Price : $8.95]
FDA issues NATCO Pharma an eight-item Form FDA-483 after concluding an inspection of the firms Telangana, India, manufacturing fac...[ Price : $8.95]
FDA warns Omaha, NE-based Ali Pharmaceutical Manufacturing about significant CGMP deviations for active pharmaceutical ingredients...[ Price : $8.95]
FDA warns San Diego, CA-based Samm Solutions about objectionable conditions in its role as the testing facility for two nonclinica...[ Price : $8.95]
FDA accepts for priority review an X4 Pharmaceuticals NDA for once-daily, oral mavorixafor to treat individuals aged 12 and older ...[ Price : $8.95]
FDA approves a Tenaya Therapeutics IND for the company to begin a Phase 1b trial of TN-401, an adeno-associated virus serotype 9-b...[ Price : $8.95]
AdvaMed tells the National Cyber Director about domestic and international efforts involving FDA to harmonize medical device cyber...[ Price : $8.95]
Asensus Surgical recalls its Senhance Surgical System due to the potential for the devices to malfunction.