The FDA is seeking input on a new draft guidance intended to help manufacturers develop strategies for ensuring potency in human cellular or gene therapies (CGT). Source: Drug Industry Daily
BioTelemetry, owned by Philips, and its subsidiary LifeWatch Services have agreed to pay more than $14.7 million to resolve allegations that they violated the False Claims Act by knowingly submitting…
Over the past week, the FDA issued a final rule on direct-to-consumer prescription drug advertisements. The agency issued final guidance on development of drugs and biological products for rare diseases,…
The FDA will kick off the new year under another possible threat of a shutdown because lawmakers have so far failed to agree on fiscal 2024 funding for the federal…
Acclarent, a division of Johnson & Johnson, has received FDA clearance for use of its AERA eustachian tube balloon dilation system in the treatment of children age 8-17 with persistent…
A five-year-old agreement between the FDA and the Cybersecurity and Infrastructure Security Agency (CISA) on medical device cybersecurity should be updated to reflect new practices, according to a recent report…
Research updates in this edition include drug successes for multiple myeloma, COPD, breast cancer and weight loss as well as disappointments in drugs for colorectal and endometrial cancer as well…
Amazon was hit with its third FDA warning letter of the year last week, this time for selling unapproved and incorrectly labeled products that contain the active ingredient in erectile…
The FDA has issued a direct-to-final guidance on using benzene in drug manufacture and has revised a recently issued draft guidance on topical ophthalmic drug quality, an area in which…
Coming back from a complete response letter (CRL) for its Udenyca Onbody drug device combo, Coherus BioSciences has received FDA approval of the product to decrease the incidence of febrile…