Drugs
The Critical Path Institute (C-Path) is joining the CDER Office of Translational Science and the Division of Cardiology and Nephrology in an Acute Kidney Injury (AKI) Project to develop a suite of prognostic tools to improve the prediction and detection of drug-induced kidney injury (DIKI). A C-Path
Drugs
FDA is republishing fee rates for the over-the-counter (OTC) monograph drug user fee program. A Federal Register notice says the rates were authorized under the 3/2020 Coronavirus Aid, Relief, and Economic Security Act to support the modernization of the OTC monograph program. After the fees were initially
FDA Policy/General
Federal Register notice: FDA has determined for patent extension purposes the regulatory review period for CVRx’s Barostim Neo, indicated for improving symptoms of heart failure, quality of life, six-minute hall walk and functional status for patients who remain symptomatic despite treatment with guideline-directed medical therapy. The regulatory
FDA Policy/General
Federal Register notice: FDA has made available additional draft and revised draft product-specific guidances that discuss the design of bioequivalence studies to support ANDAs. To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA is requesting that any consumer organizations interested in participating in the selection of voting and nonvoting consumer representatives to serve on its advisory committees or panels to notify FDA in writing. FDA is also requesting nominations for voting and nonvoting consumer representatives to serve on advisory
Devices
FDA has cleared a Rapid Medical 510(k) for its TigerTriever revascularization device for use in treating ischemic stroke. The stent retriever offers intelligent control, enabling neuro interventionalists to better remove blood clots and restore blood flow in the brain following an ischemic event, according to the company. Clearance was
Drugs
EMD Serono says there are several things FDA should consider as it continues planning a workshop on “Best Practices for Development and Application of Disease Progression Models.” In a 3/22 comment letter, the company asks the agency to consider: * best practices for machine learning and artificial intelligence in the
Biologics
FDA says an 11/16-11/25/20 Bioresearch Monitoring Program inspection at a clinical study site maintained by Michael Levin, Las Vegas, NV, as the clinical investigator for a redacted study found objectionable conditions that violated the regulations governing the proper conduct of clinical studies involving investigational new drugs.
Devices
FDA has cleared an Aurora Spine 510(k) for its proprietary Apollo Anterior Cervical Plate system, featuring a 1.9mm design with hyper-angulation variability in the Cephalad Caudal and screw angulation of 32 degrees. The company says the device is designed to help reduce common postoperative complications — such as
Biologics
FDA says it is requiring the addition of language in the Warnings and Precautions section of labeling for GlaxoSmithKline’s Shingrix (zoster vaccine recombinant, adjuvanted) describing the risk for Guillain-Barré Syndrome (GBS) following administration of the shingles vaccine. An agency safety communication says the new language reports that in
Drugs
A suit filed by Arbor Pharmaceuticals in a Georgia federal court challenging an FDA determination concerning the withdrawal of its original Nymalize (nimodipine) “raises interesting questions of statutory interpretation and the scope of FDA’s powers,” according to attorney Sarah Cork (Proskauer Rose). Writing in an online post, Cork says
Drugs
A 3/25 FDA advisory committee voted 19 to 1 that a Pfizer-proposed Risk Evaluation and Mitigation Strategy (REMS) in its BLA for osteoarthritis drug tanezumab subcutaneous injection does not ensure that the drug’s benefits outweigh its risks. FDA reviewers told panel members that the REMS was not
FDA Policy/General
Federal Register notice: FDA has determined that 20 drug products were not withdrawn from sale for safety or effectiveness reasons. The determination means that the agency will not begin procedures to withdraw ANDAs that refer the drug products, and it will continue to approve ANDAs that refer to the products
Devices
A multi-state settlement with Boston Scientific Corp. will require it to pay $188.6 million to 47 states and the District of Columbia to settle allegations that it deceptively marketed its transvaginal surgical mesh devices to patients. A statement issued by the California Department of Justice says the state
Biologics
CBER has released its strategic plan for 2021-2025 containing four goals. CBER director Peter Marks says the plan is based on the Center’s mission and vision and outlines the goals, objectives, and strategies designed to further the mission and vision during the plan’s five-year term. “Our
Devices
FDA has granted Tempus a breakthrough device designation for its artificial intelligence electrocardiogram (ECG) Analysis Platform. The device, which was developed in collaboration with Geisinger, is intended to aid clinicians in identifying patients at increased risk of developing atrial fibrillation (AFib) or atrial flutter. It was designed for use with
Drugs
Exela Pharma Sciences is asking FDA to refund FY 2021 PDUFA user fees assessed against the company’s nicardipine HCl injection and stop assessing user fees in the future. A 3/18 citizen petition says that to help facilitate the prompt refund of the user fees that were “improperly assessed,
FDA Policy/General
Federal Register notice: FDA has revised its list of bulk drug substances (active pharmaceutical ingredients) for which there is a clinical need in drug compounding. The notice identifies one bulk drug substance that FDA has considered and proposes to include on its list — quinacrine hydrochloride. Additionally, FDA has identified four
FDA Policy/General
Federal Register notice: FDA is announcing a 6/23 public workshop entitled “FY 2021 Generic Drug Science and Research Initiatives Workshop.” The workshop is intended to provide an overview of science and research initiatives for generic drugs. To view the notice, click here.
Drugs
FDA has issued a refusal to file letter for Novo Nordisk’s 1/20 label expansion application for once-weekly semaglutide 2.0 mg to treat Type 2 diabetes. The company says the agency requested additional information including data relating to a proposed new manufacturing site. “While additional information needs
Drugs
FDA has denied an 8/3/06 petition from the governors of Kansas, Minnesota, Vermont, and Wisconsin asking that the agency issue product-specific guidance for the development of insulin and human growth hormone (HGH) that are therapeutically equivalent to branded products approved by FDA. The petition also asked that
Drugs
At the 1/13 meeting of the PDUFA 7 reauthorization FDA and Industry Manufacturing Subgroup, the two sides continued discussions around a CMC readiness pilot for certain products. A meeting summary shows that both the agency and industry representatives saw potential benefit in a pilot and discussed the duration of