Devices
Artificial Intelligence/Machine Learning (AI/ML) regulatory principles are in greater flux and progressing at a greater rate than any other area of FDA regulatory oversight. That’s the view of attorney Jesse Atkins (Gardner Law) in an online post. “In a discipline as dynamic as this,” he writes, “the
Drugs
FDA and the Lupus Research Alliance have launched the Lupus Accelerating Breakthrough Consortium (Lupus ABC) focused on addressing challenges affecting lupus clinical trial success. An agency announcement says Lupus ABC “will convene people living with lupus, medical societies, industry, academic clinical researchers and scientists, FDA, and other federal agencies to
Drugs
FDA has approved Emergent BioSolutions’ Narcan 4 mg naloxone hydrochloride nasal spray, the first nonprescription over-the-counter product for reversing the effects of opioid overdose. “In accordance with a process to change the status of a drug from prescription to nonprescription, the manufacturer provided data demonstrating that the drug
Biologics
Janssen Pharmaceutical says that due to business concerns it is scrapping development of an investigational respiratory syncytial virus adult vaccine and discontinuing the related Phase 3 EVERGREEN study. The decision, it says, was made after the company reviewed its “portfolio to prioritize the most transformational assets for ongoing investment, and
FDA Policy/General
Federal Register notice: FDA has submitted to OMB an information collection extension entitled “Testing Communications by FDA’s Center for Devices and Radiological Health.” The collection supports research around CDRH’s educational and public information programs. To view the notice, click here.
Drugs
Attorneys Joshua Oyster and Rebecca Williams (Ropes & Gray) say recent FDA actions “potentially signal a broader shift in FDA’s approach to accelerated approval drugs.” Writing in an online post, they note the agency plans to hold workshops this year to discuss the role of surrogate efficacy endpoints, their
Devices
FDA has published a draft guidance, Orthopedic Non-Spinal Bone Plates, Screws, and Washers—Premarket Notification (510(k)) Submissions, with recommendations for such submissions for non-resorbable bone plate, screw, and washer devices. The document says the devices are installed for orthopedic bone fixation and exclude indications for spinal, mandibular,
Drugs
The DC federal court has granted final judgment to Vanda Pharmaceuticals in its Freedom of Information Act (FOIA) fight with FDA to obtain agency records created during the review of Vanda’s sNDA for Hetlioz (tasimelteon) to treat jet lag disorder. In the suit, Vanda complained that FDA had denied
Drugs
A 9/12-9/19/22 FDA inspection at Cornea Associates of Texas, in Dallas, TX, found “objectionable conditions” in the facility’s role as the sponsor and Dr. Tyrone McCall’s role as the authorized representative of the sponsor and clinical investigator for two clinical investigations. A 3/22
Drugs
Merck says it will meet with regulatory authorities about an expanded indication after reporting results from the Phase 3 NRG‑GY018 trial of its anti-PD-1 therapy Keytruda being evaluated in combination with standard-of-care chemotherapy (carboplatin and paclitaxel) then continued as a single agent every six weeks
Drugs
The chairs of the House Energy and Commerce Committee and its subcommittees on health and oversight and investigations are asking FDA commissioner Robert Califf for detailed information on drug shortages. In a 3/27 letter, the committee leaders said, “FDA states that it monitors ongoing drug shortages and works closely
FDA Policy/General
Federal Register notice: FDA is making available a final guidance entitled “Soft (Hydrophilic) Daily Wear Contact Lenses — Performance Criteria for Safety and Performance Based Pathway.” The document provides performance criteria for soft (hydrophilic) daily wear contact lenses to support submissions under the alternative pathway. To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA is making available a final guidance entitled “General Considerations for Animal Studies Intended to Evaluate Medical Devices.” The document is intended to assist medical device sponsors, testing facilities, and other persons involved in designing, conducting, and reporting the results of animal studies that are conducted to
Biologics
Reps. Brett Guthrie (R-KY) and Anna Eshoo (D-CA), the chair and ranking member of the House Energy and Commerce Committee’s Health Subcommittee, have written to CBER director Peter Marks expressing concern about an increase in the number of clinical holds on BLAs for cell and gene therapies.
Biologics
U.S. Representatives Mariannette Miller-Meeks (R-IA), Greg Murphy (R-NC), Nanette Barragán (D-CA), and Annie Kuster (D-NH) have introduced the Biologics Competition Act, a bipartisan bill that would order HHS to evaluate the process by which interchangeable biological products are approved and designated for substitution purposes
Drugs
GSK says it plans to submit a BLA supplement by 7/1 after reporting interim results from its RUBY/ENGOT-EN6/GOG3031/NSGO Phase 3 trial investigating Jemperli (dostarlimab) plus standard-of-care chemotherapy (carboplatin-paclitaxel) followed by dostarlimab compared to chemotherapy plus placebo followed by placebo in adult patients
Drugs
FDA says it has approved labeling changes for vismodegib (Genentech’s Erivedge) and glasdegib maleate (Pfizer’s Daurismo) to include information on musculoskeletal adverse reactions and recommendations to obtain baseline serum creatine kinase (CK) and monitoring of CK levels. The announcement of the labeling changes is in the agency’s
Devices
FDA is making available a final guidance entitled “General Considerations for Animal Studies Intended to Evaluate Medical Devices.” The document is intended to assist medical device sponsors, testing facilities, and other persons involved in designing, conducting, and reporting the results of animal studies that are conducted to assess device safety
Biologics
BrainStorm Cell Therapeutics says it has refiled a BLA under the agency’s “file-over-protest procedure” for NurOwn, a stem cell therapy for treating amyotrophic lateral sclerosis (ALS and also known as Lou Gehrig’s Disease). On 11/10/2022, the agency issued a refusal to file letter for
Drugs
FDA says that it is now resuming in-person face-to-face (FTF) meetings with generic drug industry members in a “phased-in approach” while also allowing the option to hold a videoconference meeting. “Initially, the in-person FTF meeting option will only be available for pre-ANDA product development
Devices
FDA is making available a final guidance entitled “Soft (Hydrophilic) Daily Wear Contact Lenses – Performance Criteria for Safety and Performance Based Pathway.” The document provides performance criteria for soft (hydrophilic) daily wear contact lenses in support of the Safety and Performance Based Pathway. Under this framework, companies planning to submit
Devices
FDA has cleared a Vaporox 510(k) for its next-generation VHT-200 medical device system for healing chronic wounds. “Vaporox’s Vaporous Hyperoxia Therapy (VHT) is a breakthrough technology that has been clinically validated as a safe and effective adjunct treatment for healing skin wounds,” the company says. VHT