Drugs
The majority of U.S. Supreme Court justices hinted during oral arguments 3/26 that they were skeptical whether there should be a ban or any new restrictions on the abortion drug mifepristone. Late last year, the high court agreed to hear arguments in an appeal of the 5th Circuit
FDA Policy/General
Federal Register notice: FDA is issuing an order to debar Phillip Leonowens for a period of five years from importing or offering for import any drug into the U.S. Under a plea agreement, Leonowens acknowledged that he agreed to receive, repackage, and reship prescription drugs that he received from
FDA Policy/General
Federal Register notice: FDA is announcing support for the Clinical Data Interchange Standards Consortium Standard for Exchange of Nonclinical Data Implementation Guide—Animal Rule Version 1.0 effective 3/26. The standards will be required in submissions to CBER for studies that start after 3/15/2027. The agency will
Drugs
FDA has published a revised draft guidance, Handling and Retention of BA and BE Testing Samples, with recommendations for NDA and ANDA applicants and contract research organizations (CROs) about the procedures for handling reserve samples from relevant bioavailability (BA) and bioequivalence (BE) studies. The document highlights: * how the test article
Drugs
An FDA 12/19/2022-1/10/2023 Bioresearch Monitoring Program inspection of the clinical site operated by Dr. Bret Rutherford at the New York State Psychiatric Institute in New York, NY, found objectionable conditions. A 3/21 Warning Letter says Rutherford failed to ensure that the investigation was conducted
Biologics
Mesoblast says it will refile next quarter its BLA for remestemcel-L for treating pediatric steroid-refractory acute graft versus host disease (SR-aGVHD) following favorable guidance from FDA regarding the company’s clinical data. On 8/4/2023, the agency issued a second complete response letter that requested more
Drugs
FDA has issued a warning to not use certain over-the-counter analgesic products that are marketed for topical use to relieve pain before, during or after certain cosmetic procedures, such as microdermabrasion, laser hair removal, tattooing and piercing. The agency also issued Warning Letters (see below) to six companies
FDA Policy/General
Federal Register notice: FDA is announcing that it is withdrawing approval of the indications for treating adult patients with advanced ovarian cancer for poly (ADP-ribose) polymerase (PARP) inhibitors under three NDAs — Clovis Oncology’s Rubraca (rucaparib), AstraZeneca’s Lynparza (olaparib), and GlaxoSmithKline’s Zejula (niraparib). The agency had earlier
Drugs
CDER has created a new Center of Excellence (CoE) for Quantitative Medicine (QM), which it says involves the “development and application of exposure-based, biological, and quantitative modeling and simulation approaches derived from nonclinical, clinical, and real-world sources to inform drug development, regulatory decision-making, and patient care.” The
FDA Policy/General
Federal Register notice: FDA is publishing a list of information collections that have been approved by OMB. They are: * Approval Expires Extralabel Drug Use in Animals * Premarket Notification for a New Dietary Ingredient * Food and Drug Administration Rapid Response Surveys * Application for Participation in Food and Drug Administration Fellowship Programs
Devices
Medline Industries is recalling (Class 1) certain kits, trays and packs in direct response to Nurse Assist’s 11/2023 recall of 0.9% sodium chloride irrigation USP and sterile water for irrigation USP, due to sterility concerns. The kits contain Nurse Assist saline solution that was previously recalled due
Drugs
FDA has approved Johnson & Johnson’s Opsynvi, a combination single tablet of macitentan, an endothelin receptor antagonist (ERA), and tadalafil, a phosphodiesterase 5 (PDE5) inhibitor, for treating adults with pulmonary arterial hypertension (PAH, World Health Organization [WHO] Group I) and WHO functional class (FC) II-III. The company says
Biologics
FDA has issued Regeneron Pharmaceuticals two complete response letters (CRLs) on its BLA for odronextamab in relapsed/refractory (R/R) follicular lymphoma (FL) and in R/R diffuse large B-cell lymphoma (DLBCL) after two or more lines of systemic therapy. “The only approvability issue is related to the enrollment
Devices
FDA is again proposing to ban electrical stimulation devices intended to reduce or stop self-injurious or aggressive behavior. The agency has determined that this rare regulatory move is necessary because the devices present an unreasonable and substantial risk of illness or injury. FDA issued a final rule in 2020
FDA Policy/General
A new Government Accountability Office (GAO) report says FDA needs to evaluate its recruitment and retention efforts to support and maintain its investigator workforce. The report notes that FDA has faced challenges recruiting and retaining investigators, “resulting in fewer inspections and a less experienced workforce. For example, FDA was unable
FDA Policy/General
Federal Register notice: FDA is announcing a 4/12 Oncologic Drugs Advisory Committee meeting. Panel members are scheduled to discuss the use of minimal residual disease (MRD) as an endpoint in multiple myeloma clinical trials, including considerations regarding timing of assessment, patient populations, and trial design for future studies that
Devices
Teleflex/Arrow International is recalling (Class 1) the Arrow QuickFlash Radial Artery Catheterization Set (wire, guide, catheter) device due to reports about a potentially defective component. “The complaints received relate to resistance of the guidewire handle/chamber during use,” a recall notice says. “The possible immediate health consequences of the
Drugs
FDA has approved Italfarmaco’s Duvyzat (givinostat), an oral drug for treating Duchenne Muscular Dystrophy (DMD) in patients six years of age and older. “Duvyzat is the first nonsteroidal drug approved to treat patients with all genetic variants of DMD,” an FDA release says. “It is a histone deacetylase (HDAC)
FDA Policy/General
Federal Register notice: FDA is issuing an order to permanently debar Martin Valdes from providing services in any capacity to a person that has an approved or pending drug product application. The order is based on his felony conviction for making false statements in his capacity as principal investigator responsible
Drugs
The Federal Trade Commission has filed an amicus brief calling out Teva Pharmaceuticals for “improperly listed patents” in FDA’s Orange Book and urging the court to order them removed. “Improper Orange Book listings can harm competition by delaying the entry of cheaper generic products,” according to the brief. The
Drugs
FDA has granted Invivyd an emergency use authorization for Pemgarda (pemivibart) and its use for pre-exposure prophylaxis of Covid-19 in certain adults and adolescents. Pemgarda is authorized for those who are not currently infected with SARS-CoV-2 and who have not had a known recent exposure to
Drugs
FDA has agreed to settle a lawsuit brought by three physicians who objected to the agency’s messaging during the Covid-19 pandemic that consumers should stop taking ivermectin because it was for treating horses. A court had earlier ruled (see earlier story) that when the agency issued its “You