Devices
FDA has cleared an Envisionit Deep AI 510(k) for its artificial intelligence (AI)-assisted chest x-ray device, Radify Triage, for triaging pneumothorax and pleural effusion, which the company says are two critical findings that represent significant challenges in emergency rooms and intensive care units. “Radify showed significant clinical
FDA Policy/General
Federal Register notice: FDA is announcing the issuance of Emergency Use Authorizations for 22 medical Covid-related medical devices authorized in 2023. The authorizations contain, among other things, conditions on the emergency use of the authorized products, and they include an explanation of the reasons for issuance. To view the
FDA Policy/General
Federal Register notice: FDA is making available a draft guidance entitled “Good Manufacturing Practice for Active Pharmaceutical Ingredients (APIs) Used in Veterinary Medicinal Products.” The document provides recommendations on GMPs associated with manufacturing APIs under an appropriate system for managing quality. It is also intended to help ensure that APIs
Biologics
The CBER Office of Compliance and Biologics Quality says its review of a Web site maintained by Vitacell Biologics in Lewisburg, TN, found the company is illegally selling cellular products derived from human umbilical cords and an exosome product. A 1/16 untitled letter lists Web site testimonials for the
Drugs
FDA has released the form FDA-483 issued following a 9/18-10/24/2023 inspection at the STAQ Pharma of Ohio outsourcing facility in Columbus, OH. The two inspection observations were: * failing to conduct media fills that closely simulate aseptic production operations under the worst-case, most challenging, and
Drugs
CBER director Peter Marks and Office of Therapeutic Products director Nicole Verdun say that as of 12/31/2023, FDA was aware of 22 cases of T-cell cancers that occurred after treatment with chimeric antigen receptor (CAR) T-cell products. Writing in the New England Journal of Medicine, Marks
Drugs
FDA has published a guidance, Revising ANDA Labeling Following Revision of the RLD Labeling, to assist applicants and holders of ANDAs to update their labeling following revisions to the approved labeling of the reference-listed drug. The document provides recommendations for identifying reference-listed drug labeling updates and submitting ANDA
Drugs
CDER and CBER have accepted the first artificial intelligence-based and digital health technology-based project and the first project in neuroscience in the Innovative Science and Technology Approaches for New Drugs (ISTAND) pilot program. An agency statement says the accepted letter of intent submission is for an automated depression
FDA Policy/General
FDA has published a Veterinary International Conference on Harmonization guidance, Good Manufacturing Practice for Active Pharmaceutical Ingredients Used in Veterinary Medicinal Products, to give guidance regarding good manufacturing practice for the manufacturing of active pharmaceutical ingredients (APIs) under an appropriate system for managing quality. The document says it also is
Drugs
FDA is buying a one-year subscription to digiM Solution’s I2S (Image to Simulation) integrated image processing platform based on the company’s proprietary cloud technology. A company announcement says I2S is an “end-to-end software combining data management, artificial intelligence image processing, structural analytics, and imaged-based
Drugs
Pharmaceutical Research and Manufacturers of America (PhRMA) says it supports the expanded use of innovative clinical trial approaches since they offer the potential for more patient-focused, efficient, timely, and targeted product development to support regulatory decision-making. Responding to an FDA call for comments on an upcoming workshop on
FDA Policy/General
Twenty-eight non-profit groups representing the CBD (cannabidiol) and hemp industries are calling on Congress to hold a hearing soon on FDA’s regulation, or lack thereof, of the growing market. In a 1/24 letter to the House Energy and Commerce Committee, the groups urge a hearing to
Drugs
FDA has published a guidance, ANDA Submissions — Amendments and Requests for Final Approval to Tentatively Approved ANDAs, to assist applicants in preparing and submitting amendments to tentatively approved ANDAs, including requests for final approval. The document provides recommendations on the timing and content of amendments to tentatively approved ANDAs to
Biologics
FDA has issued Theratechnologies a complete response letter on its supplemental BLA for a F8 formulation of Egrifta SV (tesamorelin), indicated for reducing excess abdominal fat in adults with HIV and lipodystrophy. The company says the letter cited issues related to chemistry, manufacturing and controls concerning the microbiology, assays, impurities
FDA Policy/General
Federal Register notice: FDA has submitted to OMB an information collection extension entitled “Regulations for In Vivo Radiopharmaceuticals Used for Diagnosis and Monitoring — 21 CFR Part 315.” The collection supports agency regulations that require manufacturers of diagnostic radiopharmaceuticals to submit information that demonstrates the safety and effectiveness of a new
FDA Policy/General
Federal Register notices: FDA announces that a priority review voucher was redeemed in the approval of the following products: * Astellas Pharma’s Veozah (fezolinetant), indicated for treating moderate to severe vasomotor symptoms, or hot flashes, caused by menopause (see notice here.) * Novartis’ Cosentyx (secukinumab) for treating active non-radiographic axial
Devices
CDRH says its Office of Strategic Partnerships and Technology Innovation (OST) has been elevated to a super office. The new designation allows the Center to be “well-positioned and capable of adapting to and addressing future public health needs and challenges while continuing to advance the voice of patients, innovation
Drugs
Lilly subsidiary Akouos says the Phase 1/2 AK-OTOF-101 study demonstrated pharmacologic hearing restoration within 30 days of administering AK-OTOF, a gene therapy, in the first trial participant, an individual with more than 10 years of profound hearing loss. A company statement says the first study participant
Drugs
Haleon is recalling eight lots of Robitussin Honey CF Max Day Adult and Robitussin Honey CF Max Nighttime Adult due to concerns about microbial contamination. “In immunocompromised individuals, the use of the affected product could potentially result in severe or life-threatening adverse events such as fungemia or disseminated fungal
Devices
FDA has granted Amadix a breakthrough device designation for PreveCol, a blood test for early detection of colorectal cancer. “PreveCol has demonstrated to have the potential to offer a great significant benefit to patients and has proven to have better diagnostic efficacy than currently approved colorectal cancer screening tests in
Drugs
FDA has granted fast track designation to Kyverna Therapeutics’ KYV-101, an autologous, fully human CD-19 chimeric antigen receptor (CAR) T-cell product candidate to treat patients with refractory progressive multiple sclerosis. A company statement says KYV-101 specifically targets CD19, a protein expressed on the surface of B
Drugs
A 5/8-5/12/2023 FDA inspection at the Glicerinas Industriales drug manufacturing facility in Zapopan, Mexico, found significant deviations from current good manufacturing practice (CGMP) regulations for active pharmaceutical ingredients. A 1/16 Warning Letter says the specific deviations were: * failing to test the identity of each batch