EIRs/483s
FDA has approved an IntelGenx 505(b)(2) NDA for RizaFilm VersaFilm (rizatriptan benzoate) for treating acute migraine. The company says RizaFilm is a proprietary orally disintergrating thin-film formulation of rizatriptan benzoate, the active ingredient in Merck’s Maxalt. IntelGenx says FDA completed a “successful pre-approval inspection” earlier
Devices
FDA has approved a BlackSwan Vascular PMA for its Lava Liquid Embolic System for treating peripheral arterial hemorrhage. The company describes the device as a “liquid embolic product” specifically indicated for embolization of peripheral arterial hemorrhages. Liquid embolic agents are injected as a liquid and solidify after entering the vasculature,
Drugs
Having accepted a proposal from FDA chief scientist Namandjé Bumpus for an advisory committee to review and address a 2021 CDER refusal to approve a company NDA for ITCA 650 (exenatide in DUROS device), Itarcia is expressing concerns about the committee’s composition and functioning. Minutes of a 4/3
FDA Policy/General
House Committee on Oversight and Accountability chairman James Comer (R-KY) is putting pressure on FDA over its late January claim that it could not regulate cannabidiol (CBD) products as dietary supplements (see earlier story). Comer sent a 4/14 letter to Robert Califf saying his committee is investigating the
FDA Policy/General
Federal Register notice: FDA has announced an opportunity for public comments on an information collection extension entitled “FDA Human Cells, Tissues, and Cellular and Tissue-Based Products — 21 CFR Part 1271.” The collection helps support the implementation of statutory and regulatory requirements that govern certain human cells, tissues, and cellular
FDA Policy/General
Federal Register notice: FDA is correcting a 4/11 notice entitled “Vaccines and Related Biological Products Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments” that contained an incorrect docket number. This is now corrected to reflect Docket No. FDA-2023-N-1338. To view the
Drugs
Researchers from FDA and RTI International say data displays in prescription drug advertising geared to healthcare providers are often “highly complex.” Writing in Therapeutic Innovation & Regulatory Science, the researchers say information conveyed in prescription drug promotion data displays vary in their presentation and complexity. The study characterized the content
Drugs
An FDA 10/31-11/8/22 inspection at the Royal Chemical Company drug manufacturing facility in East Stroudsburg, PA, found significant violations of current good manufacturing practice (CGMP) regulations for finished drugs. A 4/5 Warning Letter says specific violations were: * failing to establish and follow adequate written procedures
Devices
A 5/16-5/19/22 FDA inspection at an Abbott Point of Care Canada facility in Ottawa, Canada, found multiple violations in the firm’s manufacturing of the i-STAT cTnI test intended for the quantitative measurement of cardiac troponin I in whole blood or plasma. A just-released
FDA Policy/General
Federal Register notice: FDA is announcing a 6/7-8 public workshop entitled “Rare Disease Endpoint Advancement Pilot Program Workshop: Novel Endpoints for Rare Disease Drug Development.” The workshop is being conducted by the Duke-Robert J. Margolis, MD Center for Health Policy under a cooperative agreement. Meeting sessions will
FDA Policy/General
Federal Register notice: FDA is announcing the issuance of an emergency use authorization (EUA) to Cue Health for the Cue Mpox (Monkeypox) Molecular Test. The EUA is based on HHS’ 8/9/2022 determination that there is a public health emergency related to the monkeypox virus and the need for
Drugs
A joint meeting of the FDA Psychopharmacologic Drugs Advisory Committee and the Peripheral and Central Nervous System Drugs Advisory Committee 4/14 voted 9 to 1 that an Otsuka Pharmaceutical and Lundbeck a sNDA for Rexulti (brexpriprazole) provided sufficient data to allow identification of a population in whom the benefits
Devices
FDA has cleared an Abbott 510(k) for a reader for its FreeStyle Libre 3 integrated continuous glucose monitoring system. The reader is a small handheld device that displays real-time glucose readings obtained from a small sensor worn on the back of a person’s upper arm, allowing them
Drugs
Avenue Therapeutics says it has had a Type C meeting with FDA to map out a plan for resubmitting a twice-rejected NDA for intravenous (IV) tramadol for treating post-operative pain. “The purpose of this meeting was to discuss and reach agreement with the FDA on the proposed study
Drugs
GSK says it will submit an NDA by 6/30 for antibiotic gepotidacin and its use in treating uncomplicated urinary tract infections (uUTI) in female adults and adolescents. The submission will be based on “positive results” from the pivotal EAGLE-2 and EAGLE-3 Phase 3 trials that were stopped
FDA Policy/General
After 15 years at the agency, FDA associate commissioner for regulatory affairs Judith McMeekin has announced her retirement effective 6/30 – with many below her to follow suit thereafter. Speaking at a 4/14 Alliance for a Stronger FDA budget update, McMeekin said her deputy Carol Cave will serve as
Drugs
FDA has approved a Gamida Cell Ltd. BLA for Omisirge (omidubicel-onlv), a modified allogeneic (donor) cord blood-based cell therapy to speed recovery of neutrophils in the body and reduce infection risks. The therapy is intended for use in adults and pediatric patients 12 years and older with blood
Biologics
Federal Register notice: FDA is making available a revised draft guidance entitled “Assessing the Irritation and Sensitization Potential of Transdermal and Topical Delivery Systems for ANDAs.” The document provides recommendations for the design and conduct of studies to evaluate the in vivo skin irritation and sensitization potential of a proposed
Drugs
FDA has issued Eli Lilly a complete response letter on its BLA for mirikizumab and its use for treating ulcerative colitis (UC). In the letter, the agency cited issues related to the proposed manufacturing of mirikizumab, “with no concerns about the clinical data package, safety, or label for the medicine,
FDA Policy/General
Federal Register notice: FDA has made available a revised draft guidance “Assessing Adhesion With Transdermal and Topical Delivery Systems for ANDAs.” The document, which revises a 2018 draft guidance under the same title, provides recommendations for designing and conducting studies evaluating the adhesion performance of a transdermal or topical delivery
FDA Policy/General
Federal Register notice: FDA has made available a final guidance entitled “Peripheral Percutaneous Transluminal Angioplasty (PTA) and Specialty Catheters — Premarket Notification (510(k)) Submissions.” The submission recommendations apply to PTA balloons and specialty catheters (e.g., infusion catheters, PTA balloon catheters for in-stent restenosis, scoring/cutting balloons). To view
Drugs
The U.S. Supreme Court has ordered an administrative stay until 4/20 of a lower court’s 4/7 order (see earlier story) that would restrict the distribution of the abortion drug mifepristone. The stay gives the high court additional time to review a 4/14-filed appeal by