FDA Policy/General
Federal Register notice: FDA is seeking comments on a new information collection entitled “Yale-Mayo Clinic Centers of Excellence in Regulatory Science and Innovation (CERSI) B12 Pediatric Device Survey.” The survey is intended identify the barriers that prevent product developers from entering the pediatric device market as well as the
Drugs
FDA is likely to expand its use of new FDA Medical Queries (FMQs ) on many NDAs and BLAs during their safety reviews, and incorporating the results in labeling, according to former CDER Office of Cardiology, Hematology, Endocrinology, and Nephrology director Ellis Unger, who earlier this year joined Hyman, Phelps &
Drugs
FDA has posted a draft guidance entitled Ethical Considerations for Clinical Investigations of Medical Products Involving Children. The draft outlines and explains fundamental concepts for the ethical framework that IRBs, sponsors and industry should consider when reviewing or conducting clinical trials involving children, such as scientific necessity for conducting it
Devices
FDA has granted QT Imaging a 510(k) clearance for its QTscan to calculate the fibroglandular volume of the breast and the ratio of that to total breast volume. “This ratio can contribute to an assessment of risk for breast cancer and changes in this ratio can be used to
Devices
Philips Respironics has recalled (Class 1) certain BiPAP (bi-level positive airway pressure) ventilators that may contain a plastic contaminated with a non-compatible material. “If that plastic is in the device motor, it may release certain chemicals of concern called volatile organic compounds (VOCs),” an FDA recall notice says.
Drugs
FDA has made available an “immediately-in-effect guidance” entitled Exemption and Exclusion from Certain Requirements of the Drug Supply Chain Security Act (DSCSA) for the Distribution of FDA-Approved Naloxone Products During the Opioid Public Health Emergency. The document is intended to increase public availability of, and access to,
FDA Policy/General
Federal Register notice: FDA has submitted to OMB an information collection extension entitled “Abbreviated New Animal Drug Applications — Section 512(b)(2) and (n)(1) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360b(b)(2) and (n)(1))” (OMB Control Number 0910-0669). The collection
FDA Policy/General
Federal Register notice: FDA has renewed its Arthritis Advisory Committee for an additional two years. The new charter will be in effect until 4/5/2024. To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA has made available a final guidance entitled “Electronic Submission Template for Medical Device 510(k) Submissions.” The template is intended to serve as a guided submission preparation tool for industry to improve submission consistency and enhance efficiency during the review process. The document provides further standards
Drugs
Pharmaceutical Research and Manufacturers of America (PhRMA) says FDA should expand the Oncology Center of Excellence (OCE) Real-Time Oncology Review (RTOR) program to include human cell and tissue products regulated by CBER and products using digital health technologies in support of their applications. Commenting on an agency RTOR draft
Drugs
The Association for Accessible Medicines (AAM) says it appreciates FDA’s efforts in providing a draft guidance on therapeutic equivalence (TE) evaluations and the assignment of TE codes. The AAM says its members have suggestions for how the draft guidance can provide even more transparency into FDA’s TE evaluations
FDA Policy/General
The CDER Office of Prescription Drug Promotion (OPDP) is taking comments on a proposal to study endorser status and actual use of a drug product in TV direct-to-consumer (DTC) ads. A Federal Register notice says the proposal would extend an OPDP study currently underway that is looking at
FDA Policy/General
The CDER Office of Prescription Drug Promotion (OPDP) is proposing two research studies on different aspects of drug promotion. A Federal Register notice says the first study will examine patient and healthcare provider perceptions about prescription drugs that have medication tracking capabilities. The notice says that to improve adherence to
Devices
FDA has approved the treatment of non-left main bifurcation lesions with the Medtronic provisional bifurcation stenting technique using the Onyx Frontier and Resolute Onyx drug-eluting stents. Medtronic says it is the only company to be approved for this indication in the U.S. The company says bifurcation lesions
Devices
FDA has cleared an Iterative Scopes 510(k) for SKOUT, a real-time computer-aided polyp detection device for adults undergoing colorectal cancer screening or surveillance. The device uses advanced computer vision technology designed to recognize suspicious tissue and provide real-time feedback to gastroenterologists, the company says. The clearance
Drugs
Senate Health, Education, Labor and Pensions Committee leaders have reached a compromise to reauthorize FDA’s user fee programs for an additional five years. The reauthorization package, which is “practically clean” with few policy riders, will likely be attached to a continuing resolution that Congress is expected to take up
Drugs
FDA has granted regular approval to Eli Lilly for its previously accelerated-approval Retevmo (selpercatinib) for treating adult patients with locally advanced or metastatic non-small cell lung cancer with a rearranged during transfection (RET) gene fusion, as detected by an FDA-approved test. The agency also approved Thermo Fisher
Drugs
Staff in the FDA Oncology Center of Excellence say new procedures are needed for oncology drug accelerated approvals to shorten the time between approval and the completion of a confirmatory study. “The time between accelerated approval and verification or refutation of clinical benefit is a period of uncertainty,” the staffers
Drugs
FDA’s Oncologic Drugs Advisory Committee 9/22 voted 9-4 against recommending accelerated approval for Spectrum Pharmaceuticals’ Pozenveo (poziotinib) and its use in treating patients with previously treated locally advanced or metastatic non-small cell lung cancer harboring human epidermal growth factor receptor 2 exon 20 insertion mutations. FDA
FDA Policy/General
Former U.S. Attorney Gregory Brower says a 9/15 Department of Justice (DoJ) memo provides additional details on what will be an increased focus on corporate enforcement action. Writing in a Washington Legal Foundation Legal Pulse, Brower says the memo followed a presentation by deputy attorney general Lisa Monaco
Drugs
FDA has made available a draft guidance entitled “How to Obtain a Covered Product Authorization.” The document describes how eligible product developers can obtain such authorizations from FDA under the CREATES Act. The law provides a pathway to obtain product samples needed to fulfill testing and other regulatory requirements from
FDA Policy/General
Federal Register notice: FDA has determined that GlaxoSmithKline’s prescription-only NIX (permethrin) 1% topical creme rinse was not withdrawn from sale for reasons of safety or effectiveness. However, because NIX (permethrin) 1% topical creme rinse has been approved for nonprescription use, any generic product referencing prescription NIX would be