Drugs
The Koch-supported Taxpayers Protection Alliance has issued a report, Reforming the FDA: Saving Money, Saving Lives, calling on the agency to “pursue a series of reforms that, if enacted, would save consumers millions of dollars and millions of lives. Across all divisions of the agency, a more permissive approach
Drugs
FDA says a “Bioanalytical Methods Template” technical specifications guidance is available for industry to use. An agency notice says the guidance provides ready-to-use templates that sponsors can use to submit summaries of bioanalytical methods used in clinical pharmacology studies that require pharmacokinetic concentration evaluation. Templates in the guidance
Drugs
FDA has approved Gilead Sciences’ Descovy (emtricitabine 200 mg and tenofovir alafenamide 25 mg) for use in at-risk adults and adolescents weighing at least 35kg for HIV-1 pre-exposure prophylaxis (PrEP) to reduce the risk of HIV-1 infection from sex, excluding those who have receptive vaginal sex.
Drugs
Nippon Shinyaku says it has completed submission of a rolling NDA for its viltolarsen that is under development to treat Duchenne muscular dystrophy amenable to exon 53 skipping. The company says the drug is expected to generate functional dystrophin proteins and be effective for Duchenne muscular dystrophy amenable to dystrophin
Devices
FDA has cleared a Biofourmis 510(k) for its machine-learning and artificial intelligence (AI)-powered Biovitals Analytics Engine as a medical device for ambulatory physiological monitoring. The device “receives physiologic data such as heart rate, respiratory rate and activity in near real-time from FDA-cleared sensors and leverages
FDA Policy/General
Federal Register notice: FDA has corrected a 6/4 Federal Register notice withdrawing approval of five ANDAs for pemoline products because it contained an incorrect Web site address for an archived Web page of a Postmarket Drug Safety Information for Healthcare Professionals communication that the agency issued 10/2005. That
Drugs
FDA has denied three requests included in a 5/6 citizen petition submitted on behalf of Zydus Pharmaceuticals relating to its Mephyton (phytonadione) vitamin K1 tablets. The company had asked that the agency: * require that manufacturers of generic phytonadione tablets establish sameness with the reference-listed-drug (RLD) Mephyton by
Drugs
FDA has granted Verastem an orphan drug designation for Copiktra (duvelisib) for use in treating T-Cell lymphoma. The therapy is currently approved in the U.S. for treating chronic lymphocytic leukemia/small lymphocytic lymphoma after at least two prior therapies have failed, and accelerated approval in follicular lymphoma after
Drugs
FDA says it has opened a new Web page — FY 2018 GDUFA Science and Research Outcomes — to provide greater transparency into “the important work the agency engages in to advance the science of generic drugs and provide generic drug developers, applicants, and FDA reviewers essential tools and information to help
FDA Policy/General
President Donald Trump reportedly will nominate University of Texas MD Anderson Cancer Center chief medical executive Stephen Hahn to be FDA commissioner. BioCentury says sources familiar with the decision informed it of the choice. The nomination reportedly would be announced following completion of FBI background checks. Hahn is said to
Drugs
FDA says it is continuing to test ranitidine products (see earlier story) from multiple manufacturers and is assessing the potential impact on patients who have been taking the product that has been found to contain a nitrosamine impurity called N-nitrosodimethylamine (NDMA). In addition, the agency has asked ranitidine manufacturers
Biologics
FDA has made available a final guidance entitled Further Testing of Donations that are Reactive on a Licensed Donor Screening Test for Antibodies to Hepatitis C Virus. The document provides recommendations and asserts that each donation found to be reactive must be further tested using a licensed, approved or cleared
Drugs
FDA has published a guidance, Investigational Enzyme Replacement Therapy Products: Nonclinical Assessment, to help sponsors develop and conduct nonclinical studies during development of investigational enzyme replacement therapy (ERT) products. Specifically, the document describes the agency’s current thinking about the substance and scope of nonclinical information needed to support start
Devices
FDA has cleared a Turner Imaging Systems 510(k) for its Smart-C Mini-C Arm Portable Fluoroscopy and X-Ray Imaging Device. What makes this device unique is its true mobility and portability. The device weighs 16 pounds, allowing it to be hand-carried to the point of care.
Drugs
GlaxoSmithKline and Innoviva have submitted a supplemental NDA seeking an additional indication for once-daily use of Trelegy Ellipta (fluticasone furoate/umeclidinium/vilanterol) for treating asthma in adults. Trelegy Ellipta was originally approved 9/2017 for treating patients with chronic obstructive pulmonary disease (COPD). The submission is based on data
Drugs
Johnson & Johnson has agreed to pay $20.4 million to resolve claims by two Ohio counties relating to the company’s role in promoting opioid use. Reuters reports that J&J will pay $10 million to Cuyahoga and Summit counties, reimburse $5 million of their legal and other
Devices
The International Medical Device Regulators Forum has issued a draft guidance, Principles and Practices for Medical Device Cybersecurity, “to provide fundamental concepts and considerations on the general principles and best practices to facilitate international regulatory convergence on medical device cybersecurity.” The document is intended to provide concrete recommendations to all
Drugs
The National Institutes of Health (NIH) has awarded $29 million to fund five additional hubs to speed the translation of biomedical discoveries into commercially viable diagnostics, devices, therapeutics, and tools to improve patient care and enhance health. The newly selected Research Evaluation and Commercialization Hubs expand a national network of
Drugs
FDA has accepted for priority review a Merck NDA for Dificid (fidaxomicin) for oral suspension, and a supplemental NDA for a new indication for Dificid tablets and oral suspension for treating Clostridium (also known as Clostridioides) difficile infections in children aged six months or older. The macrolide antibacterial is currently
Drugs
FDA has approved a Puma Biotechnology labeling supplement for Nerlynx (neratinib) for the extended adjuvant treatment of HER2-positive early stage breast cancer. The label now includes safety information that is based on interim results from Puma’s Phase 2 CONTROL trial, a study evaluating dose escalation in reducing neratinib-
FDA Policy/General
Federal Register notice: FDA has determined that 24 drug products were not withdrawn due to safety or effectiveness reasons. The determination permits FDA to approve ANDAs that reference the products as long as they meet relevant legal and regulatory requirements. To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA announced a 11/13-14 Immunology Devices Panel of the Medical Devices Advisory Committee meeting to discuss immunological responses related to metal-containing products regulated as medical devices. The discussion will focus on metal-containing implants as well as dental amalgam. To view the notice, click