Drugs
Arvinas has submitted an NDA for vepdegestrant for treating patients with estrogen receptor-positive human epidermal growth factor receptor 2-negative ESR1-mutated advanced or metastatic breast cancer previously treated with endocrine-based therapy. The submission is based on results from VERITAC-2 (NCT05654623), a Phase 3 trial evaluating vepdegestrant
Devices
FDA says a Draeger 3/3 recall of VentStar Flex and Anesthesia Circuit kits is Class 1. An FDA notice says the company updated the use instructions on the breathing circuits after receiving reports that cracks may form in the hose during use. The cracks may cause leaks, the notice
Drugs
FDA has published the International Council for Harmonization (ICH) Clinical Electronic Structured Harmonized M11 Technical Specification guidance. The document says its purpose is to be a technical representation of the ICH M11 protocol template. “This technical specification is aligned with the latest version of the ICH M11 guideline and protocol
Drugs
The House Appropriations Committee 6/4 released FDA’s budget bill for FY 2026 that mirrors the Trump Administration’s budget proposal posted earlier this week (see story). The budget proposal shows that beginning 10/1 the agency’s overall budget would decrease by 4% ($271 million) to $6.8
Drugs
FDA has granted platform technology designation for Sarepta Therapeutics’ rAAVrh74 viral vector used in its investigational SRP-9003 (bidridistrogene xeboparvovec) to treat limb-girdle muscular dystrophy type 2E/R4. A company statement says it is one of the first programs to receive the FDA designation. To be eligible for the
Drugs
FDA has released a draft guidance entitled “Hernia Mesh — Package Labeling Recommendations.” The recommendations are being issued to address “suboptimal device selection associated with these devices has resulted in serious adverse events, including deaths,” the guidance says. They are intended to supplement labeling recommendations in Section XI of the agency’
Drugs
All drug labeling has been updated to be more useful for pregnant women, according to CDER acting director Jacqueline Corrigan-Curay. The changes had been sought by Sens. Maggie Hassan (D-NH) and Ted Budd (R-NC). A statement issued by Hassan says that although the labeling system was replaced
Drugs
In a 6/5 petition, California, Massachusetts, New Jersey, and New York are asking FDA to remove the current shared risk evaluation and mitigation strategy (REMS) program for the abortion drug mifepristone (Mifeprex and its generics) in their states. The petition says it was submitted in response to HHS secretary
FDA Policy/General
FDA commissioner Marty Makary has promised that the agency will listen to stakeholder ideas on reducing regulatory barriers and evolving its processes by “challenging deeply held assumptions on how we do things if it means we can deliver more cures and meaningful treatments, safe and effective to the American people.
Devices
A 1/6-1/9 FDA inspection at DFI Co., Ltd. in Gimhae, Gyeongsangnam, Korea, found Quality System Regulation violations in the firm’s manufacturing of Cybow reagent strips for urinalysis. A 5/6 Warning Letter says the specific violations were: * failure to establish and maintain adequate procedures for receiving,
FDA Policy/General
Three Morgan Lewis attorneys say FDA’s decision to use artificial intelligence (AI) to help agency reviewers should spur regulated companies to prepare to evaluate and respond to reviews that reflect AI input. Writing in an online post, the attorneys say that if the AI tool flags a concern or
Devices
FDA is announcing three Class 1 recalls (device corrections) by Smiths Medical related to certain CADD [computerized ambulatory delivery device]-Solis Ambulatory Infusion Pumps and CADD-Solis VIP Ambulatory Infusion Pumps. Smiths Medical has notified affected users about the following corrections: * Infusion Pump False Occlusion Alarm: Under certain conditions, a
Drugs
An 8/26-8/30/2024 FDA inspection at the Huangshi Hygienic Material Medicine Co. in Huangshi Shi Hubei Sheng, China, found significant violations of current good manufacturing practice (CGMP) regulations for finished drugs. A just-released 3/24 Warning Letter says the specific violations were: * failure to have for
Drugs
Vigil Neuroscience says it is discontinuing its Phase 2 long-term extension study of investigational therapy iluzanebart based on disappointing results in patients with adult-onset leukoencephalopathy with axonal spheroids and pigmented glia (ALSP), a rare and fatal neurodegenerative disease. The company’s IGNITE trial, an open-label study evaluating
Drugs
FDA has released a draft guidance entitled “Recommendations for Complying With Over-the-Counter Monograph Procedure for Minor Changes C001: Minor Changes to Solid Oral Dosage Forms for Certain Over-the-Counter (OTC) Monograph Drugs.” The document provides recommendations for how requestors can comply with the requirements described in a
Drugs
A 1/9-1/15 FDA inspection at Evi Labs in Medley, FL, found significant violations of current good manufacturing practice (CGMP) regulations for finished drugs. A 5/14 Warning Letter says the specific violations were: * failure to have for each batch of drug product appropriate laboratory determination of satisfactory
Devices
FDA has released a draft guidance entitled “Transfer of a Premarket Notification (510(k)) Clearance – Questions and Answers.” The document provides information on the most frequently asked questions regarding the transfer or sale of a 510(k) clearance from one application holder to another. It discusses topics related to a
Devices
A roundtable of experts convened by the Government Accountability Office (GAO) says HHS should have a coordinated national approach to diagnostic testing for pandemic threats. A GAO report outlines steps FDA and other HHS units can take to support such an approach. While the roundtable suggested nearly 100 actions HHS
Drugs
Two former FDA officials are part of a group of seven former HHS employees who have filed a class-action wrongful termination lawsuit alleging the federal government knowingly used flawed and inaccurate personnel records during a controversial reduction-in-force (RIF) mass termination effort back in April. Former FDA chief
FDA Policy/General
Two anonymous sources said to be familiar with the artificial intelligence (AI) tools FDA is rolling out to speed agency reviews and approvals tell NBC News the rollout may be moving too quickly. The sources said CDRH-GPT, still in beta testing in CDRH, is buggy, doesn’t yet connect
Drugs
FDA commissioner Martin Makary says the agency will conduct a review of the abortion drug mifepristone. Makary included the pledge in a 6/2 letter to Sen. Josh Hawley (R-MO), according to an online National Review story. Makary declined to comment further to the newsletter due to ongoing litigation
Biologics
In a contentious interview on CBS’s Face the Nation 6/1, FDA commissioner Marty Makary struggled to sort out and clarify the federal government’s shifting stance on Covid-19 vaccinations for healthy children and pregnant women — stressing a move away from universal recommendations and toward individualized, doctor-guided