Drugs
FDA has issued a draft guidance entitled “Registration and Listing of Cosmetic Product Facilities and Products: Guidance for Industry.” The agency was given authority under the Modernization of Cosmetics Regulation Act of 2022 (MoCRA) to require manufacturers to submit cosmetic product listings, including a list of ingredients used in these
Drugs
FDA has approved Astellas Pharma’s Izervay (avacincaptad pegol intravitreal solution) for treating geographic atrophy (GA) secondary to age-related macular degeneration (AMD). As AMD progresses, retinal cell loss and the underlying blood vessels in the macula results in “marked thinning and atrophy of retinal tissue,” the company says. “Geographic
Drugs
FDA has cleared an Abbott 510(k)for its Alinity h-series hematology system for use by laboratories to run complete blood counts (CBC). The device includes Alinity hq, an automated hematology analyzer, and Alinity hs, an integrated slide maker and stainer, according to the company. It also leverages Abbott’
Drugs
FDA has issued Mesoblast a second complete response letter on its BLA for remestemcel-L for treating pediatric steroid-refractory acute graft versus host disease (SR-aGVHD), requesting more data to support marketing approval. “To obtain the data required, Mesoblast will conduct a targeted, controlled study in the highest-risk
Devices
FDA has approved new labeling for several Biosense Webster cardiac ablation devices to be used without relying on a fluoroscopy workflow to perform procedures. “The updated workflow indicates that direct imaging guidance, such as ultrasound, may be used as an alternative to fluoroscopy,” the company says, adding that reducing fluoroscopy
FDA Policy/General
Federal Register notice: FDA is making available a final guidance entitled “Waivers, Exceptions, and Exemptions from the Requirements of Section 582 of the Federal Food, Drug, and Cosmetic Act.” The document describes the process an authorized trading partner or other stakeholder should use to request a waiver, exception, or exemption
FDA Policy/General
Federal Register notice: FDA has determined that K–TAB (potassium chloride) extended-release tablets were not withdrawn due to safety or effectiveness concerns. The determination will allow the agency to approve ANDAs for potassium chloride extended-release tablets if all other legal and regulatory requirements are met. FDA may not
FDA Policy/General
Federal Register notice: FDA has issued an order permanently debarring Raidel Figueroa from providing services in any capacity to a person that has an approved or pending drug product application. The debarment is based on Figueroa’s 8/2022 guilty plea and conviction for his role as CEO of Pharmatech
Drugs
After reporting two patient deaths, Regeneron says it has discontinued enrollment in a Phase 1 prostate cancer study of REGN5678, the company’s PSMAxCD38 costimulatory bispecific antibody, used in combination with a full-dose of its programmed death receptor-1 inhibitor Libtayo (cemiplimab-rwlc). The company says it plans to
Drugs
FDA has announced a new drug safety initiative that aims to develop artificial intelligence (AI) models for toxicological endpoints that are key to assessing drug safety and may help evaluate drug candidates before they are tested in human trials. Called SafetAI, the initiative involves FDA’s National Center for Toxicological
Drugs
FDA has posted a final guidance entitled “Recommended Acceptable Intake Limits for Nitrosamine Drug Substance-Related Impurities (NDSRIs).” The document provides manufacturers and applicants of drugs, including prescription and over-the-counter (OTC) drug products, with a recommended framework for predicting the mutagenic and carcinogenic potential NDSRIs that could be
FDA Policy/General
Federal Register notice: FDA is announcing a 10/18-19 public meeting entitled “Mitigating Clinical Study Disruptions During Disasters and Public Health Emergencies.” The meeting will satisfy the mandate of the Food and Drug Omnibus Reform Act of 2022 (FDORA) to convene a public meeting on clinical study flexibilities initiated
FDA Policy/General
Federal Register notice: FDA is making available a draft guidance entitled “PDUFA Waivers, Reductions, and Refunds for Fixed-Combinations and Single-Entity Versions of Previously Approved Antiretrovirals under PEPFAR.” The draft guidance describes circumstances under which an applicant may be eligible for a “barrier-to-innovation” waiver under the Prescription
FDA Policy/General
Federal Register notice: FDA is making available a draft guidance entitled “Fixed-Combinations and Single-Entity Versions of Previously Approved Antiretrovirals for the Treatment or Prevention of HIV–1 Under PEPFAR.” The document addresses versions of antiretroviral (ARV) drug products for which the individual ARV drug product components are already
Drugs
A bipartisan group of 28 members of the House of Representatives is warning FDA that the 11/27 deadline for implementing provisions of the Drug Supply Chain Security Act (DSCSA) could lead to disruptions to drug supply and patient care. The group is led by Reps. Troy Balderson (R-OH)
Drugs
FDA has published a guidance, Waivers, Exceptions, and Exemptions From the Requirements of Section 582 of the Federal Food, Drug, and Cosmetic Act, describing how an authorized trading partner or other stakeholder should request a waiver, exception, or exemption from the Drug Supply Chain Security Act (DSCSA). The document also
Drugs
Washington Legal Foundation (WLF) says the 2nd Circuit Court of Appeals affirmed 7/28 a federal district court’s grant of summary judgment to Forest Pharmaceuticals in a case involving the company’s antidepressant Lexapro (escitalopram). A WLF statement says the decision was a victory for the legal advocacy organization
Drugs
FDA says CDER staff have been conducting research to analyze different bispecific antibody (BsAb) molecular formats using physiochemical and biological approaches. An online paper says the studies are not intended to develop drugs, but rather to understand how different forms of BsAbs affect quality aspects such as product characterization, bioassay
Drugs
Regeneron says it will respond to a recent FDA complete response letter (CRL) on the company’s BLA for a higher dose of Eylea (aflibercept) 8 mg to treat patients with wet age-related macular degeneration, diabetic macular edema, and diabetic retinopathy. The agency has told Regeneron and contract vial
FDA Policy/General
FDA has established a docket to receive public comments on a Reagan-Udall Foundation report outlining a potential framework for establishing a public/private partnership (PPP) to collect and analyze antimicrobial use (AMU) data from food-producing animals. An agency statement (contains a link to the report) says the report
Biologics
FDA has approved an expanded indication for Merck’s Ebola vaccine Ervebo (Ebola Zaire vaccine, live) to include its use in individuals 12 months of age and older. The vaccine was previously approved for use in individuals 18 years of age and older for prevention of disease caused by Zaire
Devices
FDA has cleared an Imeka 510(k) for its Advanced Neuro Diagnostic Imaging (ANDI) quantitative imaging software, which is intended to generate a report for medical professionals on brain white matter as an adjunct to care. The report relies on artificial intelligence diffusion MRI-based white matter imaging to evaluate