The leading publisher of FDA News, FDA Review, FDA Compliance, QSR News, and Food Drug Administration information since 1984. http://fdaweb.com/ Wed, 23 Sep 2026 18:53:31 -0500 http://fdaweb.com/login.php?sa=v&aid=D5161831 Four major stakeholders give numerous suggestions for significantly changing or improving an FDA draft guidance that revises the agency’s approach to demonstrating substantial evidence of a drug or biological product’s efficacy. Wed, 23 Sep 2026 12:29:00 -0500 http://fdaweb.com/login.php?sa=v&aid=D5161831 http://fdaweb.com/login.php?sa=v&aid=D5161830 FDA releases the Form FDA-483 with three observations from its inspection at the Columbus, OH-based STAQ Pharma Ohio outsourcing facility. Wed, 23 Sep 2026 12:16:00 -0500 http://fdaweb.com/login.php?sa=v&aid=D5161830 http://fdaweb.com/login.php?sa=v&aid=D5161828 A federal court has entered a consent decree of permanent injunction against Gold Star Distribution, Inc., prohibiting the Minnesota warehouse operator from receiving, storing or distributing FDA-regulated products until it corrects persistent insanitary conditions Wed, 23 Sep 2026 11:47:00 -0500 http://fdaweb.com/login.php?sa=v&aid=D5161828 http://fdaweb.com/login.php?sa=v&aid=D5161827 FDA says a meta-analysis performed by CDER scientists suggests that pharmacokinetic similarity studies can often yield sufficient information on biosimilar toxicity and immunogenicity that comparative clinical studies may not be needed. Wed, 23 Sep 2026 11:25:00 -0500 http://fdaweb.com/login.php?sa=v&aid=D5161827 http://fdaweb.com/login.php?sa=v&aid=D5161825 CBER issues a Standard Operating Policy and Procedure on scheduling and conducting regulatory meetings on drugs and biologics. Wed, 23 Sep 2026 11:15:00 -0500 http://fdaweb.com/login.php?sa=v&aid=D5161825 http://fdaweb.com/login.php?sa=v&aid=D5161823 Former FDA head Scott Gottlieb appears on CNBC to throw his support behind commissioner-nominee Heidi Overton on the eve of her Senate confirmation hearing. Wed, 23 Sep 2026 10:39:00 -0500 http://fdaweb.com/login.php?sa=v&aid=D5161823 http://fdaweb.com/login.php?sa=v&aid=D5161821 FDA accepts a letter of intent for a wearable sensor-based digital outcome measure designed to assess foot drop severity and gait impairment in patients with Charcot-Marie-Tooth disease type 1A. Wed, 23 Sep 2026 09:58:00 -0500 http://fdaweb.com/login.php?sa=v&aid=D5161821 http://fdaweb.com/login.php?sa=v&aid=D5161820 An FDA online post explains the benefits of CDER scientists’ work in proteomics-based biomarker discovery. Wed, 23 Sep 2026 09:27:00 -0500 http://fdaweb.com/login.php?sa=v&aid=D5161820 http://fdaweb.com/login.php?sa=v&aid=D5161819 FDA warns Phoenix, AZ-based Specialty Health Products about multiple violations in its marketing of unapproved colonic irrigation systems. Wed, 23 Sep 2026 06:44:00 -0500 http://fdaweb.com/login.php?sa=v&aid=D5161819 http://fdaweb.com/login.php?sa=v&aid=D5161818 FDA warns Houston, TX-based Empower Pharmacy that it is illegally compounding GLP-1 drugs under conditions that violate CGMP regulations. Tue, 22 Sep 2026 13:36:00 -0500 http://fdaweb.com/login.php?sa=v&aid=D5161818 http://fdaweb.com/login.php?sa=v&aid=D5161817 FDA recommends that Compass Therapeutics conduct an additional clinical trial demonstrating an overall survival benefit before submitting a BLA for tovecimig for treating previously treated, advanced biliary tract cancer. Tue, 22 Sep 2026 13:02:00 -0500 http://fdaweb.com/login.php?sa=v&aid=D5161817 http://fdaweb.com/login.php?sa=v&aid=D5161816 A new study finds that a machine learning-based approach to FDA's 510(k) medical device clearance process could reduce device recalls by nearly one-third while cutting the agency's regulatory workload by more than 40%. Tue, 22 Sep 2026 12:30:00 -0500 http://fdaweb.com/login.php?sa=v&aid=D5161816 http://fdaweb.com/login.php?sa=v&aid=D5161815 A citizen petition seeks a safety investigation and potential recall of Intuitive Surgical's da Vinci Permanent Cautery Spatula, citing reports of mechanical and electrical component failures and a recent recall involving a related robotic surgical instrument. Tue, 22 Sep 2026 12:00:00 -0500 http://fdaweb.com/login.php?sa=v&aid=D5161815 http://fdaweb.com/login.php?sa=v&aid=D5161814 FDA warns Chatsworth, CA-based kdc/one Chatsworth about CGMP violations in its production of finished drugs. Tue, 22 Sep 2026 11:12:00 -0500 http://fdaweb.com/login.php?sa=v&aid=D5161814 http://fdaweb.com/login.php?sa=v&aid=D5161813 FDA Matters blog author Steven Grossman urges the Senate HELP Committee to examine how FDA commissioner-nominee Heidi Overton intends to make regulatory decisions, including her commitment to scientific evidence, transparency and established agency procedures. Tue, 22 Sep 2026 10:54:00 -0500 http://fdaweb.com/login.php?sa=v&aid=D5161813 http://fdaweb.com/login.php?sa=v&aid=D5161812 Ardelyx says it incorporated lessons from FDA's recent prescription drug advertising enforcement actions into its first television advertising campaign for Ibsrela (tenapanor). Mon, 21 Sep 2026 12:10:00 -0500 http://fdaweb.com/login.php?sa=v&aid=D5161812 http://fdaweb.com/login.php?sa=v&aid=D5161811 Three major pharmaceutical industry associations urge FDA to revise its proposed distributed manufacturing rule to provide greater flexibility for existing multi-site manufacturing networks, clarify inspection and registration requirements, and avoid imposing additional regulatory burdens that could undermine drug supply-chain resilience. Mon, 21 Sep 2026 11:26:00 -0500 http://fdaweb.com/login.php?sa=v&aid=D5161811 http://fdaweb.com/login.php?sa=v&aid=D5161810 FDA accepts for priority review an Insmed supplemental NDA seeking traditional approval for Arikayce (amikacin liposome inhalation suspension) for treating Mycobacterium avium complex (MAC) lung disease as part of a combination antibacterial drug regimen. The agency has set a user fee review action target date of 1/28/2027. Mon, 21 Sep 2026 10:59:00 -0500 http://fdaweb.com/login.php?sa=v&aid=D5161810 http://fdaweb.com/login.php?sa=v&aid=D5161808 FDA seeks advisory committee input on the benefits and risks of GRAIL's Galleri multi-cancer early detection test after two pivotal studies showed that the blood-based screening test detected about one-third of cancers diagnosed within 12 months of testing. Mon, 21 Sep 2026 09:52:00 -0500 http://fdaweb.com/login.php?sa=v&aid=D5161808 http://fdaweb.com/login.php?sa=v&aid=D5161807 A new Government Accountability Office finds gaps in FDA's oversight of third-party organizations that review 510(k) medical device submissions, including outdated audit policies and a lack of deadlines for completing audits and communicating deficiencies to participating organizations. Mon, 21 Sep 2026 09:05:00 -0500 http://fdaweb.com/login.php?sa=v&aid=D5161807