FDA Policy/General
FDA has classified a correction involving certain ventilators manufactured by Philips as a Class I recall, warning that continued use of the devices without recommended updates could lead to serious injury or death. The action affects multiple models in the Philips Respironics Trilogy Evo platform, including Trilogy Evo, Trilogy EV300,
Drugs
FDA is signaling a potential expansion of testosterone replacement therapy (TRT) use, encouraging drugmakers to explore whether existing products could be approved to treat low libido in men with idiopathic hypogonadism, according to a new agency notice. The move marks an early regulatory step that could broaden the scope of
Drugs
The Institute for Clinical and Economic Review (ICER) has released a white paper with recommendations for improving the FDA accelerated approval pathway. The paper, “Strengthening FDA’s Accelerated Approval Pathway: Progress and Unfinished Business,” reviews recent regulatory and market changes and identifies several policies that could be adopted to improve
Devices
AdvaMed says it supports FDA’s effort to implement the 21st Century Cures Act by appropriately expanding exemptions from premarket notification for Class 2 devices where a 510(k) submission is not necessary to provide reasonable assurance of safety and effectiveness. In a comment letter, the industry trade association: * says
FDA Policy/General
President Donald Trump has nominated Dr. Erica Schwartz, a former deputy surgeon general in the first Trump administration, who spent 24 years in the U.S. Public Health Service Commissioned Corps and also was a Coast Guard rear admiral, to the post of director of the Centers for Disease Control
FDA Policy/General
Eli Lilly says it will seek expanded FDA approval by the end of the quarter for its obesity drug Foundayo (orforglipron) as a treatment for diabetes, following positive topline results from its Phase 3 ACHIEVE-4 trial. The company said the oral GLP-1 receptor agonist met its primary cardiovascular
FDA Policy/General
FDA was a recurring point of reference during a 4/16 House budget hearing featuring HHS secretary Robert F. Kennedy Jr., as lawmakers pressed the administration on drug regulation, approval timelines, and the broader competitiveness of U.S. biomedical policy. While the hearing was centered on HHS budget priorities and
Devices
A 4/1 CDRH Town Hall reviewed the new Quality Management System Regulation (QSMR) and its associated Compliance Program for medical device risk-based inspections. Office of Medical Devices and Radiological Health Inspectorate senior advisor Karen Masley-Joseph described the QMSR program that became effective 2/2. She said the
Drugs
The Contraceptive Study Group says additional Warnings and Safety Information should be added to the labeling for hormonally active contraceptives. In a petition, the group says the contraceptives have been on the market for 50 years, and in that time, numerous studies have documented side effects that can have a
Drugs
FDA has extended for three months until 11/22 its review of a Savara BLA for molgramostim inhalation solution to treat autoimmune pulmonary alveolar proteinosis. A company statement says the agency determined that the company’s responses to recent information requests constituted a major amendment that resulted in the extension
FDA Policy/General
A senior FDA official is poised to play a key role in a potential leadership overhaul at the Centers for Disease Control and Prevention, as the White House weighs naming president Trump’s former deputy U.S. surgeon general Erica Schwartz as director, according to multiple reports. Sarah Brenner, currently
FDA Policy/General
FDA has issued an updated compliance program that standardizes how inspectors evaluate manufacturing facilities tied to biologic drug applications, reinforcing a risk-based approach to oversight while tightening timelines for communication and follow-up. The program, released 4/14 and set to take effect 5/14, outlines procedures for pre-
FDA Policy/General
CDER has issued two Manuals of Policies and Procedures (MAPP) on postmarketing requirements. MAPP 6010.9 Rev. 1, Procedures and Responsibilities for Developing Postmarketing Requirements and Commitments, applies to the development of all reportable 506B postmarketing commitments (PMCs) for drugs and licensed biological products regulated by CDER, and the communication
Drugs
FDA has announced a 7/23-24 Pharmacy Compounding Advisory Committee meeting to discuss adding certain peptides to the agency’s 503A Bulks List. The meeting is presumably part of HHS’ move to reverse a 2023 FDA decision that deemed a group of peptide drugs too risky for use by
Drugs
FDA has cited significant manufacturing and data integrity deficiencies at Hikal Limited following a 2/2025 inspection of the company’s active pharmaceutical ingredient (API) facility in Jigani, near Bengaluru, India. According to a Form FDA-483 issued at the close of the inspection, investigators documented six major observations, including
Drugs
FDA has granted full approval for Travere Therapeutics’ Filspari (sparsentan), a therapy for treating patients with Focal Segmental Glomerulosclerosis (FSGS), marking the first approved medicine specifically for the rare kidney disorder. Sparsentan is described as a first-in-class medication used to slow kidney function decline in adults with primary
Drugs
FDA has published a guidance titled "Bioanalytical Method Validation for Biomarkers” to help sponsors of INDs and applicants of NDAs, BLAs, sNDAs, sBLAs, and ANDAs to validate bioanalytical methods used to evaluate biomarker concentrations. The document states that it can also inform the development of bioanalytical methods for analyzing
Drugs
A 9/29-10/16/2025 FDA inspection at the Medical Products Laboratories drug manufacturing facility in Philadelphia, PA, found significant violations of current good manufacturing practice (CGMP) regulations for finished drugs. A 4/9 Warning Letter says the firm is manufacturing unapproved new drugs and lists these CGMP violations:
Drugs
A 10/28-10/30/2025 FDA inspection at the Purolea Cosmetics Lab drug manufacturing facility in Livonia, MI, found that the firm’s drug products are adulterated in that they have been prepared, packed, or held under insanitary conditions. A 4/2 Warning Letter also lists these current good
Devices
While many elements of QMSR (Quality Management System Regulation) inspections will feel familiar, the shift as of the 2/2 compliance date toward evaluating the entire Quality Management System (QMS), the increased emphasis on risk management integration, and the broader discretion afforded to investigators “represent meaningful changes that manufacturers should
Drugs
FDA has released a draft guidance outlining how drug developers should evaluate the safety of human gene therapies that use genome editing, with a particular focus on next-generation sequencing (NGS) methods to detect unintended genetic changes. The document, titled “Safety Assessment of Genome Editing in Human Gene Therapy Products
Drugs
Exelixis, which holds an NDA for Cabometyx (cabozantinib (S)-malate), a kinase inhibitor approved for several oncology indications, is asking FDA to impose restrictions on Handa Pharmaceuticals and any other companies submitting a 505(b)(2) NDA that references Cabometyx oral tablets. An Exelixis petition says Handa’s proposed cabozantinib