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Whether Vertex Pharmaceuticals’ off-target safety analysis of its investigational sickle cell gene therapy exagamglogene autotemcel (exa-cel) is sufficient or not is the issue before an FDA advisory committee on Tuesday as it considers the therapy. 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
With the quality metrics movement resurfacing and CDER’s quality maturity model publication in the news, lately I have been giving much thought to what quality culture means and how to recognize a strong culture of quality in a pharmaceutical facility. Read More
As the first session of the 118th Congress continues, FDAnews will track important pending legislation that has been acted on since July 1, to keep you updated on laws and regulations that could impact your business. 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
An upstream occlusion alarm in certain of B. Braun’s infusion pumps that may sound when no occlusion exists and cause the pump to stop pumping caused the company to issue a recall on Sept. 23, which the FDA has now deemed as class I, the most serious type of recall. Read More
In a win for Masimo, the U.S. International Trade Commission (ITC) banned the importation of Apple watches with light-based oximetry technology that monitors heart rate and blood oxygen because the watches violate two patents held by Masimo. Read More
Over the past week, the FDA issued draft guidance on communications of off label uses of approved/cleared medical products and remote inspections of drug manufacturing and BIMO facilities.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