Drugs
FDA has posted a final guidance entitled “Providing Regulatory Submissions in Electronic Format: IND Safety Reports.” The document describes the electronic format sponsors will be required to use when they electronically submit IND safety reports for serious and unexpected suspected adverse reactions that are required under 21 CFR 312.32(
Drugs
FDA has extended by three months its review of an Applied Therapeutics NDA for govorestat (AT-007) for treating classic galactosemia. The agency review extension gives it additional time to review supplemental analyses of previously submitted data that had been provided by Applied in response to FDA’s routine information
Drugs
FDA has approved Akebia Therapeutics’ Vafseo (vadadustat) tablets to treat anemia due to chronic kidney disease in adults who have been receiving dialysis for at least three months. A company statement describes Vafseo as a once-daily oral hypoxia-inducible factor prolyl hydroxylase inhibitor that activates the physiologic response to
Drugs
Aldeyra Therapeutics says that following discussions with FDA, it will start a dry eye chamber clinical trial in the first half of 2024 in hopes of being able to resubmit its NDA for reproxalap to treat dry eye disease. “Contingent on positive results from the planned clinical trial,” a company
Drugs
FDA has released the form FDA-483 issued following a 12/2-12/20/2019 inspection at the Fusion IV Pharmaceuticals outsourcing facility doing business as Axia Pharmaceutical in Los Angeles, CA. The form contained these nine inspection observations: * buildings used in the manufacture, processing, packing, or holding of drug
Drugs
FDA says Amneal Pharmaceuticals is recalling four lots of vancomycin HCl for oral solution, 250mg/5mL. An agency notice says some bottles may have been overfilled, which can result in an over-potent dosing regimen. The notice says the error occurred during the manual bottle-filling stage of manufacturing.
Drugs
Eugia U.S. has recalled one lot (# 3MC23011) of methocarbamol injection, USP 1,000 mg/10 mL single-dose vial due to a customer product complaint about the presence of white particles floating inside a vial. “Administration of an injectable product that contains particulate matter may result in local irritation
Drugs
FDA has approved a Gilead Sciences supplemental NDA for Vemlidy (tenofovir alafenamide) 25 mg tablets as a once-daily treatment for chronic hepatitis B virus (HBV) infection in pediatric patients six years of age and older and weighing at least 25 kg with compensated liver disease. Vemlidy is described as
Drugs
CDER has issued two Manuals of Policies and Procedures (MAPP) dealing with aspects of REMS (Risk Evaluation and Mitigation Strategy) assessment. The first MAPP, Review of Proposed Methodological Approaches to Assess a Risk Evaluation and Mitigation Strategy, says REMS assessments may be required when applicants submit a supplemental application for
Drugs
FDA has released the form FDA-483 issued following a 10/31-11/15/2023 inspection at the Catalent Indiana drug manufacturing facility in Bloomington, IN. The inspection observations were: * failing to fully follow the responsibilities and procedures applicable to the quality control unit; * failing to thoroughly review any unexplained
Drugs
FDA has approved a Merck BLA for Winrevair (sotatercept-csrk) for injection for treating adults with pulmonary arterial hypertension (PAH, World Health Organization [WHO] Group 1) to increase exercise capacity, improve WHO functional class (FC), and reduce the risk of clinical worsening events. “Winrevair is the first FDA-approved activin
Drugs
FDA says its review of records submitted by Deqing Jiarou Daily Chemical Co., Ltd., in Huzhou, Zhejiang, China, identified significant violations of current good manufacturing practice (CGMP) regulations for finished drugs. A 3/18 Warning Letter says the specific violations were: * failing to conduct at least one test to verify
Drugs
Dr. Qin Sun, biologics lead in the CDER Office of Clinical Pharmacology, says the agency developed the new guidance, Clinical Pharmacology Considerations for Antibody-Drug Conjugates, “to provide comprehensive clinical pharmacology recommendations for antibody-drug conjugates (ADCs).” Speaking on a Center Guidance Recap podcast, Sun said an ADC is generally
Drugs
The majority of U.S. Supreme Court justices hinted during oral arguments 3/26 that they were skeptical whether there should be a ban or any new restrictions on the abortion drug mifepristone. Late last year, the high court agreed to hear arguments in an appeal of the 5th Circuit
Drugs
FDA has published a revised draft guidance, Handling and Retention of BA and BE Testing Samples, with recommendations for NDA and ANDA applicants and contract research organizations (CROs) about the procedures for handling reserve samples from relevant bioavailability (BA) and bioequivalence (BE) studies. The document highlights: * how the test article
Drugs
An FDA 12/19/2022-1/10/2023 Bioresearch Monitoring Program inspection of the clinical site operated by Dr. Bret Rutherford at the New York State Psychiatric Institute in New York, NY, found objectionable conditions. A 3/21 Warning Letter says Rutherford failed to ensure that the investigation was conducted
Drugs
FDA has issued a warning to not use certain over-the-counter analgesic products that are marketed for topical use to relieve pain before, during or after certain cosmetic procedures, such as microdermabrasion, laser hair removal, tattooing and piercing. The agency also issued Warning Letters (see below) to six companies
Drugs
CDER has created a new Center of Excellence (CoE) for Quantitative Medicine (QM), which it says involves the “development and application of exposure-based, biological, and quantitative modeling and simulation approaches derived from nonclinical, clinical, and real-world sources to inform drug development, regulatory decision-making, and patient care.” The
Drugs
FDA has approved Johnson & Johnson’s Opsynvi, a combination single tablet of macitentan, an endothelin receptor antagonist (ERA), and tadalafil, a phosphodiesterase 5 (PDE5) inhibitor, for treating adults with pulmonary arterial hypertension (PAH, World Health Organization [WHO] Group I) and WHO functional class (FC) II-III. The company says
Drugs
FDA has approved Italfarmaco’s Duvyzat (givinostat), an oral drug for treating Duchenne Muscular Dystrophy (DMD) in patients six years of age and older. “Duvyzat is the first nonsteroidal drug approved to treat patients with all genetic variants of DMD,” an FDA release says. “It is a histone deacetylase (HDAC)
Drugs
The Federal Trade Commission has filed an amicus brief calling out Teva Pharmaceuticals for “improperly listed patents” in FDA’s Orange Book and urging the court to order them removed. “Improper Orange Book listings can harm competition by delaying the entry of cheaper generic products,” according to the brief. The
Drugs
FDA has granted Invivyd an emergency use authorization for Pemgarda (pemivibart) and its use for pre-exposure prophylaxis of Covid-19 in certain adults and adolescents. Pemgarda is authorized for those who are not currently infected with SARS-CoV-2 and who have not had a known recent exposure to