The leading publisher of FDA News, FDA Review, FDA Compliance, QSR News, and Food Drug Administration information since 1984. http://fdaweb.com/ Thu, 13 Aug 2026 14:54:47 -0500 http://fdaweb.com/login.php?sa=v&aid=D5161621 FDA releases the Form FDA-483 issued following an inspection at India’s Reliance Life Sciences drug manufacturing facility in Navi Mumbai. Thu, 13 Aug 2026 09:16:00 -0500 http://fdaweb.com/login.php?sa=v&aid=D5161621 http://fdaweb.com/login.php?sa=v&aid=D5161620 FDA is raising questions about the risk/benefit of ADC Therapeutics’ Zynlonta as a second-line treatment for diffuse large B-cell lymphoma. Thu, 13 Aug 2026 09:02:00 -0500 http://fdaweb.com/login.php?sa=v&aid=D5161620 http://fdaweb.com/login.php?sa=v&aid=D5161619 The Department of Justice seeks an injunction to stop Steiner Biotechnology from manufacturing and marketing adulterated and misbranded dental medical devices that have been subject to FDA warnings for seven years. Thu, 13 Aug 2026 06:59:00 -0500 http://fdaweb.com/login.php?sa=v&aid=D5161619 http://fdaweb.com/login.php?sa=v&aid=D5161618 FDA posts an updated guidance outlining procedures for formal meetings between the agency and sponsors or applicants developing or seeking approval for drugs and biological products. Wed, 12 Aug 2026 11:31:00 -0500 http://fdaweb.com/login.php?sa=v&aid=D5161618 http://fdaweb.com/login.php?sa=v&aid=D5161617 CDER associate Center director for strategic initiatives Theresa Mullin retires after 28 years at the agency. Wed, 12 Aug 2026 11:28:00 -0500 http://fdaweb.com/login.php?sa=v&aid=D5161617 http://fdaweb.com/login.php?sa=v&aid=D5161616 Eli Lilly files six new lawsuits against U.S. entities it alleges are selling illegal, unapproved retatrutide products. Wed, 12 Aug 2026 11:24:00 -0500 http://fdaweb.com/login.php?sa=v&aid=D5161616 http://fdaweb.com/login.php?sa=v&aid=D5161615 A survey of 37 biotech executives shows FDA obstacles are sending more first-in-human trials overseas. Wed, 12 Aug 2026 11:00:00 -0500 http://fdaweb.com/login.php?sa=v&aid=D5161615 http://fdaweb.com/login.php?sa=v&aid=D5161614 A Center for Medicine in the Public Interest opinion column calls on FDA to more aggressively recruit and use advisory committee temporary voting members. Wed, 12 Aug 2026 10:50:00 -0500 http://fdaweb.com/login.php?sa=v&aid=D5161614 http://fdaweb.com/login.php?sa=v&aid=D5161613 Children’s Health Defense petitions FDA to ban Infants’ Tylenol and place Boxed Warnings on labeling for some other Tylenol products. Wed, 12 Aug 2026 10:02:00 -0500 http://fdaweb.com/login.php?sa=v&aid=D5161613 http://fdaweb.com/login.php?sa=v&aid=D5161612 FDA officials detailing the agency’s new expedited IND pilot program say a central feature will be a rolling pre-IND submission process. Wed, 12 Aug 2026 09:55:00 -0500 http://fdaweb.com/login.php?sa=v&aid=D5161612 http://fdaweb.com/login.php?sa=v&aid=D5161611 A petition submitted to FDA calls for the agency to create conditional nonprescription access to albuterol sulfate inhalers. Tue, 11 Aug 2026 12:12:00 -0500 http://fdaweb.com/login.php?sa=v&aid=D5161611 http://fdaweb.com/login.php?sa=v&aid=D5161610 FDA accepts for priority review a Belite Bio NDA for tinlarebant for treating Stargardt Disease Type 1. Tue, 11 Aug 2026 11:49:00 -0500 http://fdaweb.com/login.php?sa=v&aid=D5161610 http://fdaweb.com/login.php?sa=v&aid=D5161609 Resilient Pharmaceuticals resubmits an NDA for its midomafetamine capsules for a proposed indication of treating post-traumatic stress disorder. Tue, 11 Aug 2026 11:23:00 -0500 http://fdaweb.com/login.php?sa=v&aid=D5161609 http://fdaweb.com/login.php?sa=v&aid=D5161608 FDA releases the Form FDA-483 with three observations from a 2024 inspection at India’s MSN Life Sciences Unit II active pharmaceutical ingredient manufacturing facility. Tue, 11 Aug 2026 10:51:00 -0500 http://fdaweb.com/login.php?sa=v&aid=D5161608 http://fdaweb.com/login.php?sa=v&aid=D5161607 An updated Class 1 recall notice says Hamilton Medical is recommending that certain coaxial breathing circuit sets used with HAMILTON-C1, HAMILTON T-1, and HAMILTON-MR1 ventilators be removed from where they are used or sold. Tue, 11 Aug 2026 09:24:00 -0500 http://fdaweb.com/login.php?sa=v&aid=D5161607 http://fdaweb.com/login.php?sa=v&aid=D5161606 Aquestive Therapeutics says that based on new human factor and pharmacokinetic trials of its Anophylm sought by FDA in a complete response letter, it plans to resubmit the Anophylm NDA in the third quarter of 2026, seeking an indication to treat type 1 allergic reactions. Tue, 11 Aug 2026 08:47:00 -0500 http://fdaweb.com/login.php?sa=v&aid=D5161606 http://fdaweb.com/login.php?sa=v&aid=D5161605 The Justice Department says it has reached a deferred prosecution agreement with Veloxis Pharmaceuticals under which the company is paying $46 million to resolve criminal and civil allegations that it paid kickbacks to induce prescriptions of its kidney transplant immunosuppressive drug Envarsus. Tue, 11 Aug 2026 08:31:00 -0500 http://fdaweb.com/login.php?sa=v&aid=D5161605 http://fdaweb.com/login.php?sa=v&aid=D5161604 Tenax Therapeutics says its oral levosimendan candidate TNX-103 failed to meet the primary endpoint in a Phase 3 trial evaluating the treatment in patients with pulmonary hypertension associated with heart failure with preserved ejection fraction. Mon, 10 Aug 2026 12:16:00 -0500 http://fdaweb.com/login.php?sa=v&aid=D5161604 http://fdaweb.com/login.php?sa=v&aid=D5161603 President Trump signs an executive order directing the federal government to develop what the White House calls "Gold Standard Childhood Vaccine Recommendations," reducing the number of diseases for which routine childhood immunization is recommended. Mon, 10 Aug 2026 11:12:00 -0500 http://fdaweb.com/login.php?sa=v&aid=D5161603 http://fdaweb.com/login.php?sa=v&aid=D5161602 FDA appoints Sarah Ibrahim as CDER deputy center director for Regulatory Programs, a role she has been serving in an acting capacity since January. Mon, 10 Aug 2026 09:50:00 -0500 http://fdaweb.com/login.php?sa=v&aid=D5161602