Drugs
A Florida federal court has ruled that state labeling and design defect claims in a multidistrict suit against the makers, repackagers, retailers, and distributors of generic forms of Sanofi’s Zantac are preempted by federal law. Attorney Kaitlyn Stone (Faegre Drinker) says the court dismissed claims against 32 generic manufacturers
Drugs
FDA has granted Harpoon Therapeutics an orphan drug designation for HPN217 for treating multiple myeloma. The tri-specific T cell activating recombinant protein construct targets B-cell maturation antigen, which is expressed on malignant multiple myeloma cells, the company says. Last April, Harpoon announced dosing of the first patient with
Devices
The CDRH Digital Health Center of Excellence has issued its “Artificial Intelligence/Machine Learning (AI/ML)-Based Software as a Medical Device Action Plan.” An agency statement (contains a link to the action plan) says the plan is a direct response to stakeholder feedback to a 4/2019 discussion paper
FDA Policy/General
Federal Register notice: FDA is seeking comments on an information collection extension entitled “513(g) Request for Information” (OMB Control Number 0910-0705). The collection supports an agency guidance on FDA and Industry Procedures for Section 513(g) Requests for Information Under the Federal Food, Drug, and Cosmetic Act, which
FDA Policy/General
Federal Register notice: FDA is correcting a 12/21/2020 Federal Register notice seeking comments on an information collection extension entitled “Export of Food and Drug Administration-Regulated Products: Export Certificates.” The date “January 20, 2021” is being corrected to read “January 21, 2021.” To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA has announced a 2/17 meeting of the Circulatory System Devices Panel of the Medical Devices Advisory Committee.(XXX DELETE XXX) Panel members are scheduled to vote on information related to a PMA for the Lutonix 014 Drug Coated Balloon Percutaneous Transluminal Angioplasty catheter, indicated for
Drugs
FDA has accepted for priority review a Bayer NDA for finerenone, an investigational drug for patients with chronic kidney disease (CKD) and Type 2 diabetes. The submission was based on data from the Phase 3 FIDELIO-DKD trial, which were published in the 10/23/2020 New England Journal of
Drugs
FDA commissioner Stephen Hahn and principal deputy commissioner Amy Abernathy say the nation still has a limited understanding of the safety profile of cannabidiol (CBD) and many other cannabis-derived compounds, including potential safety risks for people and animals. “At FDA we see these knowledge gaps as an opportunity to
Devices
The Pew Charitable Trusts says Congress should act quickly to approve legislation establishing a “unified, risk-based FDA regulatory system for diagnostics, including laboratory-developed tests (LDTs).” A 1/11 Issue Brief says the need for congressional action was heightened by an 8/2020 HHS announcement that FDA does not
Drugs
A 1/7 petition submitted on behalf of Pharmaceutical Research and Manufacturers of America, the Partnership for Safe Medicines, and the Council for Affordable Health Coverage asks FDA not to authorize the state of Florida’s drug importation program proposal and to disclose the identities of foreign sellers for public
FDA Policy/General
In the final days of the Trump Administration, HHS is proposing two last minute policies affecting FDA that are intended to enhance transparency, efficiency, and reduce unnecessary regulation. The first policy requires more information to be made public on drug approval timelines, and the second provides waivers from premarket review
Drugs
FDA and the Duke-Margolis Center for Health Policy will hold a two-day virtual workshop focused on considerations about observational study design and conduct when using evidence from such studies to inform regulatory decisions. A workshop announcement says the 2/16-17 event will highlight preliminary results from ongoing
Devices
FDA has given PMA approval to the MicroVention WEB 17 system, a new addition to the WEB aneurysm embolization system for treating intracranial wide-neck bifurcation aneurysms. The company says the WEB 17 system features a lower profile delivery system compatible with the VIA 17 microcatheter and includes additional device
FDA Policy/General
FDA has posted its latest batch of Warning Letters that includes one medical product company. It can be accessed by clicking on the link following the summary below: Bonagens, Duluth, GA (11/17): FDA recently reviewed the firm’s Web site (https://bonagensinc.com) and determined that its products “Anti-
FDA Policy/General
HHS has overridden FDA commissioner Stephen Hahn’s choice of who will temporarily lead the Office of Chief Counsel after chief counsel Stacy Cline Amin stepped down 1/11 (see earlier story). Hahn had announced that agency career lawyer and principal deputy chief counsel Mark Raza would serve as acting
Drugs
FDA commissioner Stephen Hahn has been asked to provide a progress report on recent steps the agency has taken to combat the opioid crisis. A 1/11 letter to Hahn from 48 state attorneys general requests an update on efforts to reduce prescription opioid abuse and accidental deaths using new
FDA Policy/General
A new FDA report identifies four regulatory science strategic initiatives for 2021 — unleashing the power of data; increasing choice and competition through innovation; empowering patients and consumers; and public health emergency preparedness and response. The Advancing Regulatory Science at FDA: Focus Areas of Regulatory Science report was developed to “identify
FDA Policy/General
Federal Register notice: FDA is requesting comments on a document entitled “Potential Approach for Defining Durations of Use for Medically Important Antimicrobial Drugs Intended for Use In or On Feed: A Concept Paper.” The paper outlines a potential framework for how sponsors of new animal drug products containing medically important
FDA Policy/General
Federal Register notice: FDA is requesting that any industry organizations interested in participating in the selection of nonvoting industry representatives to serve on CDRH’s National Mammography Quality Assurance Advisory Committee notify it in writing. To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA is seeking comments on a proposed “Collection of Information for Participation in FDA Non-Employee Fellowship and Traineeship Programs.” The collection supports FDA intramural training programs through fellowship and traineeship programs. These mandatory collection forms provide FDA with information from the non-employee to: (1) Begin
Drugs
FDA chief counsel Stacy Cline Amin is stepping down effective today after leading the agency’s legal shop for over two years. “During a time of unprecedented challenges at the FDA, Stacy has played a critical role in nearly every aspect of our Covid-19 pandemic response efforts, including record
Drugs
Fresenius Kabi USA has recalled one lot of ketorolac tromethamine injection, 30 mg/mL, 1 mL fill in a 2 mL amber vial, due to the presence of particulate matter detected in reserve sample vials. No adverse event reports have been reported with the recalled lot, according to a recall