Drugs
A 3/25-3/29 FDA inspection at Outin Futures Corp.’s drug manufacturing facility in Chungcheongbuk, Republic of Korea, identified significant current good manufacturing practice (CGMP) regulation violations for finished drugs. A just-released 9/25 Warning Letter also says the firm’s Neogen Dermalogy Airy sunscreen product is
FDA Policy/General
Federal Register notice: FDA has determined that Merck Sharp & Dohme’s Noxafil (posaconazole) 100g delayed-release tablets were not withdrawn from sale due to safety or effectiveness reasons. The determination means that the agency will continue to approve ANDAs that reference the product as long as they meet all
FDA Policy/General
Federal Register notice: FDA is announcing that it issued IntraBio a priority review voucher after determining its recent approval of Aqneursa (levacetylleucine), indicated for treating Niemann-Pick disease Type C in adults and pediatric patients, met the voucher criteria for issuance. To view the notice, click here.
Drugs
FDA has released the form FDA-483 issued following a 2/6-3/19 inspection at the Qualgen outsourcing facility in Edmond, OK. The 14 inspection observations were: * failure to fully follow the responsibilities and procedures applicable to the quality control unit; * failure to follow procedures describing the handling of
Devices
FDA has cleared an iCardio.ai 510(k) for its artificial intelligence software EchoMeasure for interpreting echocardiography. The Los Angeles-based company develops machine and deep learning algorithms for analyzing ultrasound applications, with a specific focus on transthoracic echo, iCardio.ai says, adding that the software leverages a database of
Devices
FDA has approved an Iota Biosciences IDE for an early feasibility study of its investigational implantable device designed to deliver electrical stimulation directly to the bladder wall to induce contractions to help with bladder emptying in individuals impacted by underactive bladder (UAB). Iota says the agency granted a “staged approval”
FDA Policy/General
Federal Register notice: FDA is making available a final guidance entitled “Endosseous Dental Implants and Endosseous Dental Implant Abutments — Performance Criteria for Safety and Performance Based Pathway.” Under the guidance, a sponsor of an endosseous implant and endosseous implant abutment device could satisfy agency requirements to compare a new device
Devices
FDA has approved Bausch + Lomb’s EnVista Envy intraocular lens (IOL), which offers a “continuous range of vision with excellent dysphotopsia tolerance” for cataract patients, according to the company. Approval was based on clinical trial data from 332 subjects. “On average, 86% of patients reported little to no bothersomeness for
Biologics
GSK says it will submit a BLA based on recent positive data from its two Phase 3 trials (ANCHOR 1 and 2) evaluating depemokimab in chronic rhinosinusitis with nasal polyps. Both trials met their co-primary endpoints of a change from baseline in total endoscopic nasal polyp score at 52
Drugs
FDA has cleared a Heidelberg Engineering 510(k) for its Spectralis Flex Module, which the company describes as a multimodal, diagnostic imaging-only platform designed for imaging the posterior segment of pediatric and adult patients in a supine position. “The Flex Module mounts the renowned Spectralis to a movable stand
FDA Policy/General
Federal Register notice: FDA is announcing that it approved on 9/17 a product application that redeemed a priority review voucher —Novartis’ Kisqali (ribociclib) for combination use with an aromatase inhibitor for the adjuvant treatment of people with hormone receptor-positive/human epidermal growth factor receptor 2-negative Stage II
Drugs
FDA has accepted for review a PTC Therapeutics NDA for sepiapterin, which the company says is )indicated for treating pediatric and adult patients with phenylketonuria (PKU), including all age groups and the full spectrum of disease subtypes. The agency has a user fee review action target date of 7/29/
FDA Policy/General
Federal Register notice: FDA is correcting a 2/2 final rule on device GMP requirements under the Quality System regulation. It erroneously omitted the definition of “batch” or “lot” that is now being added as follows: “Batch or lot means one or more components or finished devices that consist of
FDA Policy/General
Federal Register notice: FDA is announcing the Web site location where it is posting two lists of guidance documents that CDRH intends to publish in fiscal year 2025. In addition, the agency has established a docket where interested parties may comment on guidance priority topics, propose draft language for those
FDA Policy/General
Federal Register notice: FDA is announcing the revocation of an emergency use authorization issued to Janssen Biotech for the Janssen Covid-19 vaccine. The company notified the agency that the vaccine will not be marketed and requested that the authorization be revoked. To view the notice, click here.
Drugs
FDA says it is now accepting proposals from drug companies to participate in its fiscal year 2025 site visitation program, which is part of the agency’s ongoing effort to gain deeper insight into drug development and commercial manufacturing. The CDER Office of Pharmaceutical Quality (OPQ) program allows FDA staff
Drugs
FDA has released an immediately-in-effect guidance titled "Temporary Policies for Compounding Certain Parenteral Drug Products". HHS has determined that public health emergencies (PHEs) exist as a result of manufacturing and supply disruptions caused by hurricanes Helene and Milton. This guidance describes FDA’s regulatory and enforcement
Devices
FDA has posted a final guidance entitled “Endosseous Dental Implants and Endosseous Dental Implant Abutments — Performance Criteria for Safety and Performance Based Pathway.” The document provides performance criteria for endosseous dental implants and endosseous dental implant abutments under CDRH’s Safety and Performance-Based Pathway. Under the framework, entities planning
Drugs
FDA has approved a Pfizer BLA for Hympavzi (marstacimab-hncq) for preventing or reducing bleeding episodes in patients aged 12 and older with hemophilia A or B who do not have inhibitors to factor VIII or IX, respectively. The approval marks the first treatment to target a specific protein involved
Drugs
Denali Therapeutics says its strategic partner Sanofi has decided to discontinue a Phase 2 study evaluating the safety and efficacy of oditrasertib (SAR443820/DNL788) on serum neurofilament light chain levels in participants with multiple sclerosis. In a SEC filing, Denali says the study failed to meet primary and key secondary
FDA Policy/General
Federal Register notice: FDA is announcing that it approved a product submission that redeemed a priority review voucher — Johnson & Johnson’s supplemental BLA for Tremfya (guselkumab) for treating adults with moderately to severely active ulcerative colitis. The agency is required to publish a notice when a priority review voucher
Drugs
FDA has released the form FDA-483 issued following a 10/16-10/20/2023 inspection at Aqualex Co., Ltd., a drug and cosmetic manufacturer in Seongnam-si, Gyeonggi-do, Republic of Korea. The six inspection observations were: * failure to have in writing and fully follow the responsibilities and procedures