Drugs
FDA has told Marinus Pharmaceuticals that the efficacy and safety data resulting from the company’s Phase 3 Marigold Study using oral ganaxolone in children and adults with CDKL5 deficiency disorder appear sufficient to support the filing of an NDA. The company says that the adequacy of the data to
Drugs
FDA has granted Leading BioSciences a fast track designation for LB1148 for treating postoperative gastrointestinal (GI) dysfunction associated with pediatric heart surgery. The designation was based on the therapy’s potential to accelerate return of bowel function and reduce the risk of serious and life-threatening complications associated with corrective
Biologics
Operation Warp Speed chief adviser Moncef Slaoui has resigned at the request of the Biden administration, CNBC reports. The cable business network says the controversial former GlaxoSmithKline executive will remain in his role for a month to assist in the transition. Sources tell CNBC that Slaoui’s role in leading
FDA Policy/General
In one of its final actions in the last week of the Trump administration, HHS has issued a final rule it says is “designed to enhance HHS practices involving transparency and fairness in civil enforcement actions.” An HHS press statement (includes a link to the final rule) says the new
FDA Policy/General
Federal Register notice: FDA has submitted to OMB an information collection extension for “Extralabel Drug Use for Animals — 21 CFR 530” (OMB Control Number 0910-0325). The collection supports the Animal Medicinal Drug Use Clarification Act of 1994, which allows a veterinarian to prescribe the extralabel use of approved new
Drugs
In a 6-3 split on ideological lines, the Supreme Court has granted an FDA request to reinstate a federal requirement that women being prescribed mifepristone for a medical abortion in the early stages of pregnancy have to obtain the pill in person from a healthcare provider and sign a
Devices
Two SheppardMullin attorneys say the quick takeaway from the 1/12 publication of an FDA action plan for artificial intelligence and machine learning (AI/ML) software is that the agency will publish a guidance on change control plans, a key concept from its 4/2020 discussion paper on AI/ML
Devices
Two Hogan Lovells attorneys say FDA will begin accepting Safer Technologies Program (STeP) for Medical Devices requests 3/8. Writing in an online analysis, the attorneys outline the provisions of a 1/6 final guidance describing the voluntary program for medical device and device-led combination products that offer a
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-