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Seeking to address the growing problem of how misinformation undermines confidence in both science and the FDA, the Regan-Udall Foundation recently released a report focusing on how the FDA can deliver clear messaging to deliver improved understanding of the FDA and the products it regulates. Read More
Although Medicare will now cover antiamyloid antibodies fully approved for early Alzheimer’s and the PET imaging required to qualify for them, questions remain about how coverage will shake out for other procedures that clinicians deem necessary for these treatment regimens. Read More
In a move with ramifications for medical devicemakers, the Biden administration issued an executive order Monday targeting powerful AI systems, requiring developers to share safety test results and other critical information with the U.S. government. Read More
Virtual listening-only sessions for the public regarding the Inflation Reduction Act’s (IRA) Medicare Drug Price Negotiation Program began Monday — and will continue through mid-November — providing an opportunity for patients, beneficiaries and caregivers to provide input on a single drug in each session. Read More
The election of newly installed Speaker of the House Mike Johnson (R-La.) means the impending government shutdown on Nov. 17 almost certainly won’t occur, says Steven Grossman, executive director of the Alliance for a Stronger FDA. Read More
The FDA has issued a warning letter to Illinois drugmaker Abbott Laboratories regarding its Similac Probiotic Tri-Blend for infants, over marketing claims that render the product an unapproved new drug and unlicensed biological product, and followed up with a general notice of its concerns about the use of probiotics on preterm infants on Thursday. Read More
The FDA’s guidance on developing topical corticosteroids provides ANDA applicants with recommendations on pilot and pivotal studies to assess bioequivalence of the drugs. Read More
In this edition of Quick Notes, we cover a Philips study confirming the safety of its cardiac diagnostic device, FTC action against deceptive marketing of a COVID-19 protection device, and updates to two FDA medical device event reporting databases. Read More
The FDA has smacked UCB Farchim for quality control lapses, among other deficiencies, following an inspection of its Bulle, Fribourg, Switzerland facility in June and July. Read More
In a new draft guidance, the FDA describes how it requests and conducts voluntary remote regulatory assessments (RRA), an evaluation the agency says it may conduct in lieu of or in support of an inspection. Read More
The FDA issued a complete response letter (CRL) for Sanofi and Regeneron’s supplemental biologics license application (sBLA) for Dupixent (dupilumab) in chronic spontaneous urticaria (CSU) requesting additional efficacy data, the companies announced on Friday. Read More