PharmaTher also said it was working with its third-party manufacturing partner to resolve the deficiencies.
Boston Scientific recalls its Accolade pacemakers and Visionist and Valitude cardiac resynchronization therapy pacemakers due to the possibility of th...
Philips recalls its Tack Endovascular Systems due to customer complaints, including events where additional interventions were required to retrieve or...
Pharmaceutical Research and Manufacturers of America says FDA should make sure its recent draft guidance entitled Protocol Deviations for Clinical Inv...
Olympus recalls certain models of its endoscope single use guide sheath kits after receiving complaints about the radiopaque tip falling off into pati...
FDA orders testosterone product makers to change their drug labeling to remove a warning about risk of adverse cardiovascular outcomes in men.
FDAs ability to use its user fee carryover balances to fund product review operations during a potential government shutdown is unlikely because of se...
FDA approves an ALK supplemental BLA for Odactra (house dust mite allergen tablet) to expand its use for treating house dust mite-induced allergic rhi...
