Drugs
FDA has made available a draft guidance entitled “Acute Myeloid Leukemia: Developing Drugs and Biological Products for Treatment.” The document is intended to assist sponsors in the clinical development of drugs and biological products for treating AML. It includes the agency’s current thinking on the overall development program and
Drugs
FDA has granted accelerated approval to NS Pharma’s Viltepso (viltolarsen) to treat Duchenne muscular dystrophy (DMD) in patients who have a confirmed mutation of the DMD gene that is amenable to exon 53 skipping. An agency announcement says this is the second approved targeted treatment for patients with this
Drugs
CDER researchers say clinical pharmacologists face an unprecedented timeline for Covid-19 drug development, optimizing dose and dosing regimens for repurposed drug products to be evaluated in clinical trials. Writing in the Journal of Clinical Pharmacology, the FDAers summarize the clinical pharmacy considerations in the development of immunomodulatory therapeutic proteins
Drugs
FDA has issued a guidance, Male Breast Cancer: Developing Drugs for Treatment, with recommendations for sponsors on the development and labeling of cancer drugs, including biological products, regulated by CDER and CBER for treating male patients with breast cancer. The document says the historic exclusion of males from breast cancer
FDA Policy/General
Federal Register notice: FDA is seeking comments on an information collection entitled “Medical Devices; Humanitarian Use Devices (HUD) — 21 CFR Part 814” (OMB Control Number 0910-0332). The collection supports the agency’s authorization to exempt an HUD from effectiveness requirements. To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA is seeking comments on an information collection extension entitled “Electronic Records; Electronic Signatures — 21 CFR Part 11” (OMB Control Number 0910-0303). The collection pertains to FDA criteria for accepting electronic records, electronic signatures, and handwritten signatures executed to electronic records as equivalent to paper records.
FDA Policy/General
FDA commissioner Stephen Hahn told an 8/10 teleconference of doctors and other healthcare professionals that the agency needs their help in communicating to patients that all FDA Covid-19 decisions are based on science. “I want to reassure you that the decisions that FDA will have to make in
Drugs
FDA has approved a Lantheus and Progenics Pharmaceuticals supplemental NDA for Vialmix RFID for Definity. The product is described by the companies as a next generation activation device designed specifically for Definity Vial (perflutren lipid microsphere) for injectable suspension, an intravenous ultrasound enhancing agent. “Definity is supplied as a liquid-
Drugs
An FDA drug safety alert is warning about reports of toxic anterior segment syndrome (TASS) following intraocular administration of compounded drugs using moxifloxacin as a bulk drug substance, as well as reports associated with the intraocular administration of repackaged or diluted FDA-approved moxifloxacin. The agency has identified 29 cases
Devices
FDA has cleared a MagVenture 510(k) for its TMS Therapy as an adjunct treatment for obsessive-compulsive disorder (OCD). Previously, the device was cleared for treating major depressive disorder. The device uses repetitive transcranial magnetic stimulation to delivers magnetic pulses to stimulate nerve cells in the part of the
Drugs
FDA will give priority review to a Regeneron Pharmaceuticals BLA for evinacumab as an adjunct to other lipid-lowering therapies in patients with homozygous familial hypercholesterolemia (HoFH). The company says evinacumab is the first investigational medicine of its kind to show efficacy in patients with HoFH, including patients with little
FDA Policy/General
Federal Register notice: FDA has announced a 10/2 Vaccines and Related Biological Products Advisory Committee meeting. Panel members are scheduled to discuss and make recommendations on the selection of strains to be included in an influenza virus vaccine for the 2021 southern hemisphere influenza season. To view the notice,
FDA Policy/General
Federal Register notice: FDA has made available a final guidance entitled “Marketing Status Notifications Under Section 506I of the Federal Food, Drug, and Cosmetic Act; Content and Format.” The document recommends content for the marketing status notifications, the format for submitting them, and the timelines for submission. To view the
Drugs
FDA says its testing of Bersih hand sanitizers manufactured by Soluciones Cosmeticas, Mexico City, Mexico, determined that batches of the products were adulterated by including methanol with the ethanol active ingredient. An 8/4 Warning Letter also says the products are unapproved misbranded new drugs. The letter says the firm
Drugs
FDA has issued Fennec Pharmaceuticals a complete response letter on its NDA for Pedmark (sodium thiosulfate), for intravenous administration for preventing ototoxicity associated with cisplatin chemotherapy in pediatric patients older than one month of age with localized, non-metastatic, solid tumors. The agency’s letter cited manufacturing concerns from a
Drugs
A 6/3-6/6/19 FDA inspection at Taka USA, doing business as Cosmetic Innovations, Carrollton, TX, found significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals. A 7/29 Warning Letter says specific violations were: * failing to have for each batch of drug product appropriate
Devices
CDRH Office of In Vitro Diagnostics and Radiological Health director Timothy Stenzel says FDA has authorized over 200 SARS-CoV-2 tests in the emergency use authorization pathway. Speaking on an 8/5 virtual town hall on development and validation of coronavirus tests, Stenzel said there are “hundreds of EUA
Devices
FDA has cleared a Life Spine 510(k) for the Plateau-X Ti Lateral Lumbar Spacer System. The device is intended for use by surgeons to provide anterior column support through a lateral approach. It includes a comprehensive set of instruments and implants to streamline the surgical procedure, the company
FDA Policy/General
Rep. Raja Krishnamoorthi (D-IL) says that science shows that e-cigarette users are much more likely to be diagnosed with Covid-19 and to experience symptoms. Krishnamoorthi discussed the finding in an 8/11 letter to FDA commissioner Stephen Hahn. In the letter, the representative said he had presented
Devices
Becton, Dickinson (BD) has recalled its ChloraPrep 3 mL applicator due to possible fungal contamination, which only affects climate zone IV regions in specific U.S. territories (Puerto Rico, Guam, U.S. Virgin Islands, Northern Mariana Islands and American Samoa). These warm, high-humidity locations promote the growth of Aspergillus
Drugs
Briefing documents released by FDA in advance of an Oncologic Drugs Advisory Committee 8/13 meeting to consider the Mesoblast BLA for its Remestemcell-L as a treatment for steroid-refractory acute Graft Versus Host Disease (SR aGVHD) in pediatric patients challenge the biologic’s effectiveness and durability of patient
Drugs
Genentech says topline results from a Phase 3 safety program evaluating its investigational etrolizumab in people with moderately to severely active ulcerative colitis gave mixed results in studies evaluating the biologic as an induction therapy. In addition, studies evaluating etrolizumab as a maintenance therapy failed to meet their primary endpoints,