The leading publisher of FDA News, FDA Review, FDA Compliance, QSR News, and Food Drug Administration information since 1984. http://fdaweb.com/ Fri, 10 Apr 2026 18:54:27 -0500 http://fdaweb.com/login.php?sa=v&aid=D5160969 Representative Jake Auchincloss (D-MA) urges FDA whistleblowers to come forward to disclose instances of wrongdoing by agency managers. Fri, 10 Apr 2026 11:29:00 -0500 http://fdaweb.com/login.php?sa=v&aid=D5160969 http://fdaweb.com/login.php?sa=v&aid=D5160968 FDA issues an early alert regarding a potential safety issue affecting certain sizing catheters manufactured by Cook Medical. Fri, 10 Apr 2026 09:38:00 -0500 http://fdaweb.com/login.php?sa=v&aid=D5160968 http://fdaweb.com/login.php?sa=v&aid=D5160967 FDA cites significant manufacturing and quality control deficiencies at an active pharmaceutical ingredient facility operated by Orchid Pharma Limited in India, following an inspection last year. Fri, 10 Apr 2026 08:57:00 -0500 http://fdaweb.com/login.php?sa=v&aid=D5160967 http://fdaweb.com/login.php?sa=v&aid=D5160966 FDA issues Replimune another complete response letter, declining to approve its BLA for vusolimogene oderparepvec in combination with nivolumab for advanced melanoma. Fri, 10 Apr 2026 08:11:00 -0500 http://fdaweb.com/login.php?sa=v&aid=D5160966 http://fdaweb.com/login.php?sa=v&aid=D5160965 FDA accepts a Telix Pharmaceuticals resubmitted NDA for TLX101-Px, an investigational PET imaging agent for glioma. Fri, 10 Apr 2026 05:53:00 -0500 http://fdaweb.com/login.php?sa=v&aid=D5160965 http://fdaweb.com/login.php?sa=v&aid=D5160964 FDA cites GMP deficiencies at a facility operated by Thermo Fisher Scientific (Patheon Italia unit) in Ferentino, Italy. Thu, 9 Apr 2026 11:55:00 -0500 http://fdaweb.com/login.php?sa=v&aid=D5160964 http://fdaweb.com/login.php?sa=v&aid=D5160963 Medline Industries recalls (Class 1) its angiographic control syringes, warning the devices could cause severe injury or death. Thu, 9 Apr 2026 11:53:00 -0500 http://fdaweb.com/login.php?sa=v&aid=D5160963 http://fdaweb.com/login.php?sa=v&aid=D5160962 FDA and the device industry are nearing a final agreement on the next round of Medical Device User Fee Act (MDUFA VI) negotiations. Thu, 9 Apr 2026 11:48:00 -0500 http://fdaweb.com/login.php?sa=v&aid=D5160962 http://fdaweb.com/login.php?sa=v&aid=D5160961 Granules India Ltd tightens oversight of its manufacturing operations at its largest facility based on FDA-documented compliance issues outlined in a Warning Letter while the company awaits reinspection. Thu, 9 Apr 2026 11:27:00 -0500 http://fdaweb.com/login.php?sa=v&aid=D5160961 http://fdaweb.com/login.php?sa=v&aid=D5160960 Minutes of the 3/10 and 3/12 PDUFA 8 reauthorization steering committee sessions, progress was reported on the America First fee incentive discussion, and a fee proposal for non-orphan indication supplements. Thu, 9 Apr 2026 11:16:00 -0500 http://fdaweb.com/login.php?sa=v&aid=D5160960 http://fdaweb.com/login.php?sa=v&aid=D5160959 Vanda Pharmaceuticals says FDA should withdraw a legislative proposal in its budget package that the company says would lengthen NDA review times and hurt the legal appeal process available to companies aggrieved by an FDA decision. Thu, 9 Apr 2026 09:36:00 -0500 http://fdaweb.com/login.php?sa=v&aid=D5160959 http://fdaweb.com/login.php?sa=v&aid=D5160958 FDA cautions BioCorRx about false and misleading information on the Web site home page for its Lucemyra. Thu, 9 Apr 2026 08:30:00 -0500 http://fdaweb.com/login.php?sa=v&aid=D5160958 http://fdaweb.com/login.php?sa=v&aid=D5160957 The CDER Office of Prescription Drug Promotion says an Amneal patient brochure for its Avastin biosimilar Alymsys is false or misleading in several ways. Thu, 9 Apr 2026 07:44:00 -0500 http://fdaweb.com/login.php?sa=v&aid=D5160957 http://fdaweb.com/login.php?sa=v&aid=D5160956 HHS secretary Robert F. Kennedy Jr. curtails his public commentary on vaccines as part of a deliberate political strategy by the Trump administration for its midterm election campaign. Thu, 9 Apr 2026 07:19:00 -0500 http://fdaweb.com/login.php?sa=v&aid=D5160956 http://fdaweb.com/login.php?sa=v&aid=D5160955 Two Hyman, Phelps & McNamara attorneys describe the impacts on industry if FDA responds to a congressional push for more pre-review of direct-to-consumer ads. Thu, 9 Apr 2026 06:50:00 -0500 http://fdaweb.com/login.php?sa=v&aid=D5160955 http://fdaweb.com/login.php?sa=v&aid=D5160954 A Clinical Trial Vanguard online column explains how a 2022 FDA master protocol guidance has not kept pace with non-oncology basket trial developments. Wed, 8 Apr 2026 13:09:00 -0500 http://fdaweb.com/login.php?sa=v&aid=D5160954 http://fdaweb.com/login.php?sa=v&aid=D5160953 An FDA Matters column calls on FDA to fully enforce the laws against mass compounding of approved drugs that are not in shortage. Wed, 8 Apr 2026 12:00:00 -0500 http://fdaweb.com/login.php?sa=v&aid=D5160953 http://fdaweb.com/login.php?sa=v&aid=D5160952 FDA removes partial clinical hold against MacroGenics’ Phase 2 LINNET study evaluating the investigational cancer therapy lorigerlimab. Wed, 8 Apr 2026 11:40:00 -0500 http://fdaweb.com/login.php?sa=v&aid=D5160952 http://fdaweb.com/login.php?sa=v&aid=D5160951 Baker Hostetler attorney Winston Kirton says life sciences companies that are active in both the U.S. and the EU need to change their view of supply chains to meet new regulatory approaches. Wed, 8 Apr 2026 11:18:00 -0500 http://fdaweb.com/login.php?sa=v&aid=D5160951 http://fdaweb.com/login.php?sa=v&aid=D5160950 Insmed discontinues development of its drug candidate brensocatib for hidradenitis suppurativa after a mid-stage clinical trial failed to meet its primary and secondary efficacy endpoints. Wed, 8 Apr 2026 11:17:00 -0500 http://fdaweb.com/login.php?sa=v&aid=D5160950