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Over the past week, the FDA issued draft guidance on communications of off label uses of approved/cleared medical products and remote inspections of drug manufacturing and BIMO facilities. Read More
A new publicly searchable database contains detailed information on all 141 Alzheimer’s disease (AD)-targeting drugs involved in 187 active clinical trials in the U.S. and around the world. Read More
Sen. Bernie Sanders (I-Vt.) sent a letter to the HHS Inspector General seeking investigation into an NIH proposal granting an exclusive patent license to an “obscure company linked to a former employee” for a treatment for cervical cancer. 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
Oncologists were more likely to provide low-value cancer care drugs after receiving money from the pharmaceutical companies that make those drugs, raising questions about the harm caused to patients by the drug industry, according to a new study published in The BMJ. 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
Increasing cultural and ethnic diversity in Alzheimer’s clinical trials is a must — but it’s going to take a complete rethinking of the way these studies are recruited, conducted, and analyzed, said a Fordham University psychology professor speaking at an Alzheimer’s conference. Read More
Fresenius Medical Care has recalled some of its hemodialysis machines for the potential of exposing patients to a harmful chemical, and Olympus has recalled an insufflation unit — and the FDA has deemed both these recalls as class I, the most serious type of recall because of the potential for serious side effects including death. 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
Upcoming events in the coming weeks include four FDA advisory committee meetings as well as the 18th Annual Inspections vSummit and webinars from FDAnews, a WCG company, on what to expect from the FDA in 2024, quality culture and how to use UDI and UDI Data. Read More