Devices
A 2/19-3/11/2025 FDA inspection at Avertix Medical in Eatontown, NJ, found multiple violations in the firm’s manufacture of The Guardian System, an implantable coronary syndrome event detector. A just-released nine-page 9/3/2025 Warning Letter lists these Quality System Regulation violations: * failure to
Drugs
An unannounced 7/14-7/18/2025 FDA inspection at the Patcos Cosmetics Pvt. Ltd. drug manufacturing facility in Dadra and Hagar Haveli and Daman, India, found adulterated over-the-counter drug products that have been prepared, packed, or held under insanitary conditions, and had significant violations of current good
Drugs
FDA has issued a draft guidance encouraging drug developers to adopt new approach methodologies (NAMs) as part of a broader effort to reduce reliance on animal testing and improve the prediction of human drug safety. The document outlines a framework for validating these emerging tools, ranging from advanced cell-based
Devices
Minutes from the 2/11 and 2/18 MDUFA 6 negotiating sessions between FDA and industry representatives indicate agreement was reached on several issues, with others needing further discussion. The 2/18 minutes say the two sides have agreed to proposals on patient science, digital health, third-party 510(k)
Drugs
FDA has approved Johnson & Johnson’s Icotyde (icotrokinra) to treat moderate-to-severe plaque psoriasis in adults and some pediatric patients aged 12 and older who are candidates for systemic therapy or phototherapy. A company statement says Icotyde is the only targeted oral peptide that precisely blocks the IL-
FDA Policy/General
A pair of public health experts is calling for sweeping reforms to improve FDA’s transparency, arguing that longstanding gaps in disclosure persist despite recent progress. In a Viewpoint published 3/18 in the Journal of the American Medical Association, Irene Ulrich of the Center for Science in the Public
FDA Policy/General
FDA has released an updated version of its guidance on pyrogen and endotoxin testing, offering manufacturers of drugs, biologics, and medical devices greater clarity on regulatory expectations while reinforcing flexibility in testing approaches. The document, “Pyrogen and Endotoxins Testing—Questions and Answers (Edition 2),” aims to address areas of persistent
Devices
FDA has issued an early alert regarding a potentially serious defect in certain insulin pump components manufactured by Insulet, citing risks of improper insulin delivery. The alert applies to specific lots of the company’s Omnipod 5 Pods, a tubeless insulin delivery system used by people with diabetes. The FDA
Drugs
A 9/11-9/26/2025 FDA inspection at the Oralabs drug manufacturing facility in Parker, CO, found significant violations of current good manufacturing practice (CGMP) regulations for finished drugs in the company’s work as a contract drug manufacturer. A 3/11 Warning Letter says the specific violations were:
Drugs
A 9/8-9/12/2025 FDA inspection at the Flowchem Pharma Private Limited drug manufacturing facility in Hindupur Taluk, Andhra Pradesh, India, found significant deviations from current good manufacturing practice (CGMP) regulations for active pharmaceutical ingredients (APIs). A 3/11 Warning Letter says the specific deviations were: * failure to
Drugs
BioMarin says it is discontinuing dosing and enrollment in portions of its mid-stage clinical program for Voxzogo (vosoritide) after reports of a rare orthopedic complication emerged in external studies, marking a setback to expand the drug beyond its approved use. In 2021, FDA approved Voxzogo to improve growth in
Devices
Integra LifeSciences has recalled certain neurosurgical monitoring kits, citing potential safety risks linked to a needle component used during procedures to monitor brain pressure. The recall affects specific lots of the Codman Microsensor Basic Kit and Cerelink ICP Sensor Basic Kit, devices commonly used to measure intracranial pressure in patients
Drugs
FDA has identified multiple manufacturing and laboratory control deficiencies at Alps Pharmaceutical, following an inspection of the company’s facility in Hida City, Japan, according to an FDA Form 483. The inspection, conducted in October, targeted the firm’s active pharmaceutical ingredient (API) operations and documented lapses in quality control
Drugs
Pharmaceutical Research and Manufacturers of America (PhRMA) says it commends FDA for issuing a draft guidance, Use of Bayesian Methodology in Clinical Trials of Drug and Biological Products, to facilitate the advancement and use of complex adaptive, Bayesian, and other novel clinical trial designs. In a comment letter, PhRMA says
FDA Policy/General
Attorneys Nathan Brown and Maddy Bolger (Akin) say regulated industries should assess and incorporate the FDA suggestions in a 3/9 draft guidance, Responding to FDA Form 483 Observations at the Conclusion of a Drug CGMP Inspection, into their form FDA-483 response practices and, in particular, their corrective and
Drugs
FDA has issued Aldeyra a complete response letter (CRL) for its investigational dry eye treatment reproxalap, concluding that the company failed to provide sufficient evidence the drug is effective. The action is the third CRL issued during its regulatory history, and it follows a three-month review extension by the
Drugs
FDA has extended by three months its review of a Lantheus Holdings’ NDA for LNTH-2501, a diagnostic imaging agent targeting neuroendocrine tumors, pushing the decision date to 6/29. The review extension will allow the agency additional time to evaluate new manufacturing-related information submitted by the company. Lantheus
FDA Policy/General
A group of U.S. senators is pressing HHS to reverse recent changes to FDA and other federal health Web sites, warning that altered guidance on vaccines and autism could endanger public health as measles cases climb nationwide. In a letter to HHS secretary Robert F. Kennedy Jr., senators including
Drugs
FDA inspectors have cited multiple manufacturing and quality control deficiencies at a sterile drug production facility operated by Gland Chemicals Private Limited in Chennai, India, according to an inspection report issued to the company. The observations were documented in a Form 483 issued following an FDA inspection conducted from in
FDA Policy/General
FDA has updated an internal policy document outlining how CBER staff process supplements to approved drug and biologic applications, detailing administrative steps used during regulatory review. The document — Standard Operating Policy and Procedure (SOPP) 8401.2 Administrative Processing of BLA and NDA Supplements — provides guidance for staff on the administrative
Drugs
NRx Pharmaceuticals says it has received meeting minutes from a recent Type C guidance meeting with FDA indicating it is willing to review a potential NDA for its investigational therapy NRX-100, a preservative-free intravenous formulation of ketamine, without requiring additional clinical trials. According to the company, the meeting
Drugs
FDA has told NovaBridge Biosciences that its investigational cancer therapy givastomig could be eligible for an accelerated approval pathway following a recent Type B regulatory meeting. The company says written minutes from the meeting confirmed the agency’s willingness to consider accelerated approval for the drug in first-line treatment