FDA Policy/General
Federal Register notice: FDA is announcing that it has approved a product redeeming a rare pediatric disease priority review voucher — Incyte’s Opzelura (ruxolitinib). The JAK inhibitor was approved 9/2021 for the topical short-term and non-continuous chronic treatment of mild to moderate atopic dermatitis in non-immunocompromised
Drugs
FDA is considering more opportunities for sponsors to learn about inspection issues that arise during pre-approval/pre-licensure inspections before an application review is completed. Speaking at a joint Parenteral Drug Association/FDA regulatory conference in Washington, DC 9/9, CDER director Patrizia Cavazzoni acknowledged that there is a
Drugs
Attorneys Wyatt Kernell and Sonia Nash (Cooley) say companies should carefully review an FDA 7/8 draft guidance on addressing misinformation about medical devices and prescription drugs as part of preparing any tailored response communication to be sure their communication falls within the agency’s enforcement discretion policy. Writing in
Devices
FDA has cleared a DeepWell Digital Therapeutics 510(k) for its biofeedback software development kit for use in over-the-counter treatments for reducing stress, and as an adjunctive treatment for high blood pressure when used with other pharmacological or nonpharmacological interventions. DeepWell says it will make the new technology
FDA Policy/General
Federal Register notice: FDA is classifying whole exome sequencing devices into Class 2 (special controls). The move follows a 2019 request from Helix OpCo for the de novo classification of its Helix Learning Platform, which is used for analyzing the complete coding region of an individual’s DNA. The DNA
FDA Policy/General
FDA has granted Aisa Pharma an orphan drug designation for its investigational drug AISA-021 (cilnidipine) and its use in treating systemic sclerosis (SSc), a rare and severe autoimmune disease affecting approximately 175,000 Americans. SSc has the highest mortality rate among autoimmune diseases, according to the company, and it
FDA Policy/General
Federal Register notice: FDA is classifying blood collection devices for cell-free nucleic acids into Class 2. The action is based on a Streck Inc. request for de novo classification of its Cell-Free DNA BCT, which the agency is identifying as intended for medical purposes to collect, store, transport,
Drugs
GSK says data from its SWIFT-1 and SWIFT-2 Phase 3 clinical trials showed that depemokimab significantly reduces asthma exacerbations in patients with severe Type 2 inflammation. The findings were presented at the 9/9 European Respiratory Society International Conference in Vienna and published simultaneously in the New England
Drugs
FDA has removed a partial clinical hold against Rezolute’s RZ358 (ersodetug), a potential treatment for hypoglycemia caused by congenital hyperinsulinism. (HI) Ersodetug is currently being evaluated in the sunRIZE global Phase 3 study in participants with congenital HI, the company says, and the hold removal will permit it to
Devices
FDA has cleared a Femasys 510(k) for FemChec, a diagnostic device for checking the fallopian tubes. “When used with an intrauterine catheter, it is intended for the controlled delivery of natural contrast during an ultrasound evaluation of the fallopian tubes with or without the uterine cavity,” the company says.
Devices
The Association for Diagnostics and Laboratory Medicine (ADLM) is voicing significant concerns regarding the recent FDA final rule on laboratory developed tests (LDTs), and it is urging Congress to intervene while judicial reviews determine the agency’s authority to regulate LDTs. ADLM also urges Capitol Hill to explore separate solutions
FDA Policy/General
Federal Register notice: FDA is classifying endoscopic pancreatic debridement devices into Class 2 (special controls). The action is based on a de novo classification request submitted by Interscope, Inc. for its EndoRotor device. The device is designed to endoscopically remove necrotic tissue from a walled-off pancreatic necrosis cavity. The
Biologics
CBER has released an updated standard operating policy and procedure (SOPP) manual entitled “SOPP 8404: Refusal to File (RTF) Procedures” that has updated RTF examples and an updated Appendix A that lists examples of easily correctible deficiencies. According to the document, RTF decisions may be made based on findings such
Drugs
FDA has granted Travere Therapeutics full approval for Filspari (sparsentan) for slowing kidney function decline in adults with primary immunoglobulin A nephropathy (IgAN) who are at risk of disease progression. The therapy received accelerated approval 2/23 based on the surrogate marker of proteinuria. Full approval, the company says, is
FDA Policy/General
Federal Register notice: FDA is seeking comments on an information collection revision entitled “Pharmaceutical Distribution Supply Chain; Drug Supply Chain Security.” The collection helps support agency regulations that govern the pharmaceutical distribution supply chain. The agency says it has revised Form FDA 3911 (notification of illegitimate products) and the instructions
FDA Policy/General
Federal Register notice: FDA is making available a draft guidance entitled “Incorporating Voluntary Patient Preference Information over the Total Product Life Cycle.” The document discusses the principal concepts that sponsors and other interested parties should consider when choosing to collect and submit patient preference information (PPI). The agency says the
FDA Policy/General
Federal Register notice: FDA is announcing a 10/10 Cardiovascular and Renal Drugs Advisory Committee meeting to review a Stealth BioTherapeutics NDA for elamipretide hydrochloride injection, indicated for treating Barth syndrome. The submission is based on data from the SPIBA-001 Phase 3 Natural History Control Study and additional supporting
Drugs
GSK says “headline” results from its Phase 3 MATINEE clinical trial evaluating chronic obstructive pulmonary disease drug (COPD) Nucala (mepolizumab) met its primary endpoint — “statistically significant and clinically meaningful reduction in the annualized rate of moderate/severe exacerbations versus placebo with patients treated for up to 104 weeks.” The monoclonal
Devices
FDA has cleared an Odin Medical (an Olympus subsidiary) 510(k) for what it describes as the first cloud-based artificial intelligence technology to assist gastroenterologists in detecting suspected colorectal polyps during colonoscopy procedures. The Caddie computer-aided detection device was cleared based on data from a randomized controlled trial
Drugs
FDA has issued Regenerative Processing Plant a Warning Letter based on a 6/2023 inspection of the firm’s Palm Harbor, FL, manufacturing facility that found significant GMP violations involving its ophthalmic drug products, Regener-Eyes Professional (PRO) Ophthalmic Solution and Regener-Eyes LITE Ophthalmic Solution. Based on claims being
Drugs
An April inspection of Taenaka Kogyo (Mobara, Chiba, Japan) has resulted in a four-observation Form FDA-483 that cites significant GMP violations. For example, the agency says the firm’s training was not regularly conducted by qualified individuals, and it did not cover the operations the employees performed. The
Biologics
FDA has posted a Form FDA-483 issued to Biocon Biologics at the end of a July inspection of the firm’s Bengaluru, India manufacturing facility. The document cites 10 observations: 1. Procedures designed to prevent microbiological contamination of drug products did not include adequate validation of the aseptic process.