Archive for December 2023

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. Source: Drug Industry Daily

The FDA is seeking input on a new draft guidance intended to help manufacturers develop strategies for ensuring potency in human cellular or gene therapies (CGT).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 claims to federal government programs for a higher level of cardiac monitoring than physicians intended to order. Source: Drug Industry Daily

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 Draft guidance was issued on potency assurance for cellular and…

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.…

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. Source: Drug Industry Daily

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). Source: Drug Industry Daily

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. Source: Drug Industry Daily

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. Source: Drug Industry Daily

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. Source: Drug Industry Daily