Devices
U.S. senators Joni Ernst (R-IA) and Chuck Grassley (R-IA) have sent a letter to FDA asking for clarification on its temporary policy for manufacturing alcohol-based hand sanitizer products during the Covid-19 pandemic. In March, the agency released a temporary guidance on ethanol used in hand
FDA Policy/General
Federal Register notice: FDA has made available draft recommendations for new permitted daily exposures (PDEs) for the residual solvents 2-methyltetrahydrofuran, cyclopentyl methyl ether, and tert-butyl alcohol. The PDEs were developed according to the methods for establishing exposure limits included in the guidance for industry entitled “Q3C Impurities: Residual
Devices
Reuters reports exclusively that a shipment of Russian Aventa-M ventilators was negotiated by president Donald Trump with Russian president Vladimir Putin and was received by the Federal Emergency Management Agency (FEMA) 4/1 without oversight from FDA. The news service says the ventilators were sent to New York and
Drugs
FDA has cleared a 4DMedical 510(k) for its XV Technology, a patented four-dimensional lung imaging process that is intended to rapidly and automatically analyze any functional lung impairment from a single X-ray. “It provides critical information about the functional and structural state of a patient’s lungs
Devices
FDA says that healthcare facility reprocessing staff should remember to use the correct decontamination cycle associated with certain models of the Advanced Sterilization Products (ASP) Sterrad sterilization systems and to only decontaminate compatible N95 or N95-equivalent respirators for reuse during the Covid-19 pandemic. An agency online notice says
Drugs
FDA has approved an Amivas NDA for artesunate for injection 110 mg, powder and solvent for solution, indicated for the initial treatment of severe malaria in adult and pediatric patients. Approval was based on data from three studies, including the South East Asian Quinine Artesunate Malaria Trial (SEAQUAMAT) and the
Drugs
A 3/25-4/19/19 FDA inspection at Altaire Pharmaceuticals, Aquebogue, NY, found significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals that were repeated violations from three previous inspections. A just-released 3/12 Warning Letter said the specific violations were: * failing to establish an
FDA Policy/General
Federal Register notice: FDA has announced a 6/22 virtual public meeting entitled “Financial Transparency and Efficiency of the Prescription Drug User Fee Act, Biosimilar User Fee Act, and Generic Drug User Fee Amendments.” The meeting will include presentations from FDA on the five-year plans for drug, biosimilar and
Drugs
A 10/17-10/25/19 FDA inspection at Samchundang Pharm Co., Seoul, South Korea, found significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals. A 5/13 Warning Letter says specific violations were: * failing to establish and document the accuracy, sensitivity, specificity, and reproducibility of test
Drugs
CDER director Janet Woodcock has accepted a detail in the Office of the Commissioner to “start-up” the Trump Administration’s therapeutics initiative under its recently announced “Operation Warp Speed” for Covid-19 treatments, according to FDA commissioner Stephen Hahn. “While she focuses on this work, CDER deputy director Dr.
Biologics
CBER says there were 563 human cell, tissue, and cellular and tissue product (HCT/P) inspections conducted in Fiscal Year 2019, the lowest in the period 2015-2019. The highest was 636 inspections in 2016, according to a chart released by the Center. Of the inspections in 2019, some 440
Drugs
FDA has approved a Sanofi BLA for Dupixent (dupilumab) for children aged six to 11 years with moderate-to-severe atopic dermatitis whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable. Dupixent is a monoclonal antibody that inhibits the signalling of the
Biologics
In a 5/20 petition, Seoul, Korea, biotechnology company Cell2in is asking FDA to update applicable guidances to identify real-time glutathione monitoring methods as an acceptable means of measuring potency for purposes of submitting a BLA for cell-based therapies, including stem cell therapies. The petition says it is
Devices
FDA has published an immediately-in-effect guidance, Supplements for Approved Premarket Approval (PMA) or Humanitarian Device Exemption (HDE) Submissions During the Coronavirus Disease 2019 (Covid-19) Public Health Emergency, containing agency policy to help address current manufacturing limitations or supply chain issues due to disruptions caused by the Covid-
FDA Policy/General
FDA has posted its latest batch of Warning Letters. They can be accessed by clicking on the link following each letter. Altaire Pharmaceuticals, Aquebogue, NY (3/12): FDA inspected the firm 4/2019 and cited significant GMP violations for finished pharmaceuticals. For example, the company failed to establish an adequate
Devices
FDA has cleared a Smart Medical Systems 510(k) for the G-Eye Colonoscope. The device is a standard colonoscope which Smart remanufactures by installing its proprietary G-Eye balloon on the distal bending section of the colonoscope. During colonoscopy, the G-Eye colonoscope is inserted in the standard technique,
Drugs
FDA has posted a draft International Conference for Harmonization (ICH) guideline, Recommendations for the Permitted Daily Exposures for Three Solvents — 2-Methyltetrahydrofuran, Cyclopentyl Methyl Ether, and Tert-Butyl Alcohol — According to the Maintenance Procedures for the Guidance of Q3C Impurities: Residual Solvents. The agency says the draft was published in
FDA Policy/General
Boston Scientific has agreed to acquire NxThera, a privately-held company based in Maple Grove, MN for $306 million upfront and an additional $100 million in potential commercial milestone payments over the next four years. The transaction gives Boston Scientific the Rez?m, a treatment system for men with symptoms
Drugs
FDA says it has updated two guidances for the temporary compounding of certain human drugs during the Covid-19 public health emergency. An online notice says the updates “clarify certain policies to address urgent needs for hospitalized Covid-19 patients.” The guidance for temporary compounding of certain drugs by outsourcing
Drugs
FDA has published a list of 10 drugs in various forms and dosages for which new medication guides are available. The drugs are AbbVie’s Depakene (valproic acid), AbbVie’s Depakote (divalproex sodium), Apopharma’s Ferriprox (deferiprone), AstraZeneca’s Lynparza (Olaparib), Genentech’s Tencentriq (atezolizumab), Hoffmann LaRoche’s Zelboraf (vemurafenib)
Devices
A 5/15 CDRH virtual town hall discussed a joint FDA, National Institutes of Health (NIH), Veterans Administration (VA) project on 3D printing of nasal swabs during the Covid-19 public health emergency. Participants noted that an FDA Covid-19 policy guidance intends to help accelerate the availability of novel
Drugs
Hikma Pharmaceuticals has received approval from FDA for its icosapent ethyl capsules, 1 gm, the generic equivalent of Amarin Pharmaceuticals’ Vascepa. In March, a Nevada federal court invalidated six key Vascepa patents owned by Amarin. That decision is currently being appealed. Vascepa is indicated for use with statins to reduce