Devices
Becton Dickinson has expanded the Class 1 recall of its Alaris Pump Module model 8100 to include 15 additional infusion sets, citing potential performance issues that could lead to serious injury or death in vulnerable patients. The recall, first initiated on 7/8 and expanded on 7/17, now covers
Drugs
FDA’s ongoing crack down (see earlier story) on drug direct-to-consumer (DTC) promotional activities has led to three just-released Warning Letters to Eli Lilly and one to Novo Nordisk that cite the companies for their alleged violative claims about GLP-1 receptor agonists. In the first Lilly
Drugs
A direct-to-consumer TV ad for CSL Behring’s Hizentra (immune globulin subcutaneous (human)) overstates the drug’s effectiveness and minimizes safety information, thus misbranding it, according to a CBER Warning Letter. The letter says the Hizentra labeling describes it as a 20% liquid subcutaneous immune globulin indicated to
Devices
A 3/24-3/26 FDA inspection at SeniorLife Technologies in Bellevue, WA, determined that the firm is illegally marketing its SeniorLife.AI mobile application, intended to use artificial intelligence-based algorithms to screen and “pre-diagnose” mobility and cognitive health conditions. A just-released 8/21 Warning Letter says
Devices
FDA has issued an early alert about a Medline recall for specific lots of Medline Kits containing Medtronic DLP Left Heart Vent Catheters based on an earlier Medtronic recall due to issues identified with certain lots of cannula products where the catheter may not retain its shape. As of 7/
Drugs
A 2/10-2/21 FDA inspection at the Somerset Therapeutics Private Limited drug manufacturing facility in Bengaluru, Karnataka, India, identified significant violations of current good manufacturing practice (CGMP) regulations for finished drugs. A 9/4 Warning Letter says the specific violations were: * failure to thoroughly investigate any unexplained discrepancy
Drugs
A Center for Innovation in Regulatory Science (CIRS) briefing paper says that in recent years, there has been significant progress in reducing delays in new drug approvals in China. The latest CIRS briefing looks at new active substance (NAS) approvals in Australia, Canada, China, Europe, Japan, Switzerland, and the U.
FDA Policy/General
FDA has released 40 cease and desist (untitled) letters to drug companies that the agency said were issued earlier this month when it unveiled a major push (see earlier story) to crack down on misleading direct-to-consumer drug advertising. For example, a letter to AstraZeneca addresses a specific DTC
Drugs
FDA has posted a draft guidance entitled “Erosive Esophagitis: Developing Drugs for Treatment” that outlines recommendations for the clinical development of drugs to treat erosive esophagitis (EE) in adults. It provides a framework for drugmakers designing trials to evaluate therapies for both the healing of EE and the maintenance of
Devices
Dexcom is recalling (Class 1 device correction) its Dexcom G7 App and Dexcom ONE+ App which contain a software design error that leads to a missed “sensor failed” alert when the sensor’s transmitter encounters a hardware/firmware failure. Affected apps end the continuous glucose monitoring sensor session, stops reporting
Drugs
aTyr Pharma is reporting mixed topline results from its Phase 3 EFZO-FIT study of efzofitimod in pulmonary sarcoidosis, a chronic inflammatory lung disease. While the trial did not meet its primary endpoint, the therapy demonstrated encouraging improvements in quality-of-life measures and steroid reduction, the company says. aTyr
Drugs
FDA has granted Merck and Daiichi Sankyo a breakthrough therapy designation for raludotatug deruxtecan (R-DXd), an investigational drug for treating patients with certain forms of platinum-resistant ovarian, primary peritoneal, or fallopian tube cancers. The designation covers patients whose tumors express CDH6 and who have previously been treated with
Drugs
Tandem Diabetes Care is recalling (Class 1 device correction) certain t:slim X2 insulin pumps after identifying a potential speaker-related issue that can trigger an error that will stop insulin delivery and render the pump no longer operational. The issue is called a “Malfunction 16” error and is caused
Drugs
FDA has approved a Corstasis Therapeutics NDA for Enbumyst (bumetanide), a nasal spray loop diuretic for treating edema linked to congestive heart failure, liver disease, and kidney disease, including nephrotic syndrome in adults. The approval offers a new outpatient option for patients who often face limited choices between oral and
Drugs
FDA has issued Olympia Pharmaceuticals a three-item Form FDA-483 following a 7/28-8/8 inspection of the firm’s Orlando, FL manufacturing facility. The inspection cited Olympia over the following GMP deficiencies: * Procedures designed to prevent microbiological contamination of drug products purporting to be sterile did not
Biologics
FDA has approved a Krystal Biotech supplemental BLA for a label expansion on its gene therapy Vyjuvek (beremagene geperpavec-svdt), adding patients with dystrophic epidermolysis bullosa (DEB) from birth. The labeling now allows DEB patients and their caregivers to apply the topical gene therapy at home, rather than requiring administration
Biologics
A CBER untitled letter to AstraZeneca cites the firm for running a misleading television direct-to-consumer advertisement for its nasal spray flu vaccine FluMist, warning the company that the commercial misbrands the product and violates federal law. In the 9/9 letter from CBER director Vinay Prasad, the agency
Devices
Philips Respironics is recalling (Class 1) certain DreamStation auto continuous positive airway pressure (CPAP) and auto bilevel positive airway pressure (BiPAP) devices due to a programming error introduced during rework by a supplier, which may result in incorrect therapy modes (e.g., BiPAP configured as CPAP), limited pressure, unavailable features,
FDA Policy/General
FDA is moving to rein in direct-to-consumer (DTC) pharmaceutical advertising after decades of weak oversight allowed misleading promotions to flood the U.S. market, according to a new JAMA article by FDA commissioner Martin Makary. He called drug advertising a “public health crisis” in need of urgent intervention.
Drugs
FDA has published a guidance, Alternative Tools: Assessing Drug Manufacturing Facilities Identified in Pending Applications, giving applicants information on how the agency intends to use alternative tools to assess drug manufacturing facilities identified in NDAs, BLAs, ANDAs, or their supplements. The document meets a requirement in the PDUFA 7 and
Biologics
CBER is hosting a 10/22 virtual town hall focused on gene therapy manufacturing requirements for BLAs and post-licensure changes. The Office of Therapeutic Products event brings together experts from the Office of Gene Therapy and the Division of Manufacturing and Product Quality. FDA officials will address questions related
FDA Policy/General
FDA under President Donald Trump is pushing forward with plans discussed during the Biden Administration under commissioner Robert Califf to scale back its long-standing practice of convening independent advisory committees to review new drug applications — a shift that critics warn could reduce transparency and weaken public trust in the