Biologics
A 1/28-2/5 FDA inspection at InVia Fertility Specialists in Hoffman Estates, IL, documents significant violations of the regulations for human cells, tissues, and cellular and tissue-based products (HCT/Ps). A just-released 6/13 Warning Letter says the specific violations were: * failure to test a specimen
Drugs
A 12/13-12/20/2024 FDA inspection at the Healwell Homeo Private Limited drug manufacturing facility in Ahmedabad, Gujarat, India, found the firm’s homeopathic and over-the-counter drug products were adulterated in that they were prepared, packed, or held under insanitary conditions so they may have become
Devices
In an updated safety communication, FDA says Contec has issued a software patch to fix cybersecurity vulnerabilities in certain Contec and Epsimed patient monitors. The agency notice says the patch fully removes networking functionality from the affected monitors, making them usable only for local monitoring. In a 1/30 safety
Drugs
FDA says its review of a Web site maintained by www.buynetmeds.com determined that it is selling misbranded and unapproved new drugs. A just-released 6/12 Warning Letter says the agency observed that the site introduces into interstate commerce unapproved and misbranded opioid drug products. The letter also
Devices
FDA says Baxter has issued a letter to affected customers recommending that certain Spectrum infusion pumps be removed from where they are used or sold. An agency Early Alert said Baxter recommended that customers with the affected pumps remove them from service and check the software version installed on the
Drugs
FDA says it is revising the labeling of all extended-release stimulants intended to treat attention-deficit/hyperactivity disorder (ADHD), including certain formulations of amphetamine and methylphenidate, to warn about the risk of weight loss and other adverse reactions in patients younger than age six taking the medications. An agency
Drugs
FDA has issued a draft guidance entitled Small Volume Parenteral Drug Products and Pharmacy Bulk Packages for Parenteral Nutrition: Aluminum Content and Labeling Recommendations. The document is intended to clarify key factors in calculating the aluminum content to ensure that the total aluminum exposure (TAE) from parenteral nutrition (PN) does
FDA Policy/General
The FDA rollout of its generative artificial intelligence (AI) staff tool Elsa is in many ways a “nuanced dance between innovation and responsibility.” That’s the view of ERB Lab Services principal consultant and owner Erika Roberts, based on her more than 15 years of experience working in various areas
Devices
FDA has approved a Sirtex Medical PMA for its SIR-Spheres Y-90 resin microspheres for treating unresectable hepatocellular carcinoma (HCC) in the United States. HCC is the most common form of liver cancer in adults in the U.S., according to the American Cancer Society. Radioembolization with SIR-Spheres
Biologics
A group of medical societies has filed suit against HHS secretary Robert F. Kennedy Jr. and FDA commissioner Marty Makary to reverse a 5/27 decision (see earlier story) to revoke Covid-19 vaccine recommendations for children and pregnant people. The lawsuit was filed in the U.S. District Court
Devices
FDA has cleared an Atmo Biosciences 510(k) for the ingestible Atmo Gas Capsule System for assessing both whole and regional gut transit times — covering the stomach, small bowel, and colon — as an aid in diagnosing gastrointestinal motility disorders (gastroparesis and slow transit constipation). “By measuring regional and whole gut
Drugs
A new FDA report breaks down the demographic representation of clinical trials supporting the approval of 50 novel drug therapies approved in 2024, which involved 31,000 clinical trial participants. The report, which is intended to provide insight into persistent disparities and areas of progress in clinical research, is part
Drugs
In a move to reduce burdens on healthcare providers and improve patient access, FDA is removing risk evaluation and mitigation strategies (REMS) requirements for all currently approved BCMA- and CD19-directed autologous CAR T cell therapies, explaining that the programs are no longer necessary to ensure patient safety. The action
Drugs
UCB is announcing positive data from a Phase 3 clinical trial evaluating fenfluramine as an adjunctive treatment for CDKL5 Deficiency Disorder (CDD). The trial met both its primary and key secondary endpoints in patients with the rare and severe form of epilepsy, according to the company. The primary outcome was
Drugs
The U.S. Court of Appeals for the D.C. Circuit has upheld a lower court’s decision for FDA that a “clinically superior drug is not the same as a drug that is otherwise the same.” The appeals court reaffirmed that FDA acted correctly in determining that Avadel CNS
Drugs
Achieve Life Sciences has submitted an NDA for cytisinicline for treating nicotine dependence as part of smoking cessation in adults. The submission is based on data from two placebo-controlled Phase 3 trials, ORCA-2 and ORCA-3. “In both studies, cytisinicline administered for either six or 12 weeks, alongside
Drugs
FDA has issued safety-related labeling updates for two bile acid transport inhibitors — Mirum Pharmaceuticals’ Livmarli (maralixibat) and Ipsen Biopharmaceuticals’ Bylvay (odevixibat) — to emphasize increased risks of liver injury and bleeding associated with their use. The changes are based on new data from expanded clinical trials and postmarketing experience, an
Drugs
FDA has published a guidance, Antibacterial Therapies for Patients with an Unmet Medical Need for the Treatment of Serious Bacterial Diseases—Questions and Answers, to help sponsors in the clinical development of new antibacterial drugs to treat serious bacterial diseases, particularly those caused by antimicrobial drug-resistant organisms, in patients
Drugs
Altimmune is announcing mixed topline results today from its Phase 2b IMPACT trial evaluating pemvidutide in patients with metabolic dysfunction-associated steatohepatitis (MASH), a progressive liver disease. The study showed that pemvidutide led to significant improvements in disease resolution and weight loss, with promising signals of anti-fibrotic activity, according
Devices
FDA has posted a draft guidance entitled “Unique Device Identifier (UDI) Requirements for Combination Products.” The document discusses how the agency’s UDI requirements apply to combination products with device constituent parts. It also outlines requirements, recommendations, and best practices for UDI labeling and submission of information to the Global
Biologics
Former CBER director Peter Marks says the FDA announcement of a new “evidence-based approach to Covid-19 vaccination” is a “dramatic departure” not just from previous agency vaccine policies but also from the deliberate and measured way in which the agency previously made such policy, with open public discussion
Drugs
FDA has published a guidance, Conducting Remote Regulatory Assessments—Questions and Answers, to help enhance the industry’s understanding of such assessments, thus facilitating the process for FDA conducting the assessments. The document says the term Remote Regulatory Assessment (RRA) is used to describe a category of activities for which