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To regulate new medical device technologies, the FDA should rely on familiar regulatory processes to review low-risk activities while adopting a more attentive approach that devotes greater resources to high-risk activities, according to a former agency commissioner. Read More
The FDA is seeking input on a new draft guidance intended to help manufacturers develop strategies for ensuring potency in human cellular or gene therapies (CGT). Read More
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 claims to federal government programs for a higher level of cardiac monitoring than physicians intended to order. Read More
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, direct-to-consumer promotional labeling and advertisements and, reformulating drug products that contain carbomers manufactured with benzene. Draft guidance was issued on potency assurance for cellular and gene therapy products and quality considerations for topical ophthalmic drugs. Read More
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 government and stopgap funding is set to expire on Jan. 19 — just over one week after the House and Senate begin the new session. Read More
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 obstructive eustachian tube dysfunction (OETD), the first such treatment available for children. Read More
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 by the U.S. Government Accountability Office (GAO). Read More
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 as hyperkalemia.Read More
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 dysfunction (ED) drugs Cialis and Viagra. Read More
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 the agency has seen significant quality control issues recently. Read More
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 neutropenia after chemotherapy. Read More
This edition of Quick Notes highlights drug approvals from regulators in the U.S. and Europe, while confirming December so far has been a pretty good month for Astellas Pharma with several drug approvals in the U.S. and EU. Read More