FDA Policy/General
Federal Register notice: FDA is announcing its support for Electronic Common Technical Document (eCTD) Version 4.0 (v4.0)-based electronic submissions for CDER/CBER regulated products. The version of eCTD currently supported by the agency is specified in the FDA Data Standards Catalog (https://www.fda.gov/regulatory-information/
FDA Policy/General
Federal Register notice: FDA is correcting a notice that appeared in the 6/21 Federal Register announcing the approval withdrawal 20 ANDAs. Two ANDAs were incorrectly listed and this notice corrects the errors. To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA is announcing an 11/7 meeting of the Medical Devices Advisory Committee’s General and Plastic Surgery Devices Panel to review an IceCure Medical de novo request for its ProSense Cryoablation System. The discussion is intended to focus on the sponsor’s proposed indication: “for use
FDA Policy/General
Federal Register notice: FDA has determined for patent extension purposes the regulatory review period for Cyclomedica Australia’s Technegas (technetium Tc 99m-labeled carbon), indicated for visualization of pulmonary ventilation and evaluation of pulmonary embolism when paired with perfusion imaging. The regulatory review period is 4,322 days, of which
FDA Policy/General
Federal Register notice: FDA has determined for patent extension purposes the regulatory review period for Marinus Pharmaceuticals’ Ztalmy (ganaxolone), indicated for treating seizures associated with cyclin-dependent kinase-like 5 deficiency disorder in patients two years of age and older. The regulatory review period is 10,382 days, of which
Drugs
The Medical Information Working Group (MIWG) says it has concerns about a revised FDA question-and-answer draft guidance on addressing misinformation about medical devices and prescription drugs. In its comment, the MIWG says that despite improvements made in the current revision, it still has concerns about the guidance’s
FDA Policy/General
Federal Register notice: FDA is announcing that it has approved a product redeeming a rare pediatric disease priority review voucher — Incyte’s Opzelura (ruxolitinib). The JAK inhibitor was approved 9/2021 for the topical short-term and non-continuous chronic treatment of mild to moderate atopic dermatitis in non-immunocompromised
Drugs
Attorneys Wyatt Kernell and Sonia Nash (Cooley) say companies should carefully review an FDA 7/8 draft guidance on addressing misinformation about medical devices and prescription drugs as part of preparing any tailored response communication to be sure their communication falls within the agency’s enforcement discretion policy. Writing in
FDA Policy/General
Federal Register notice: FDA is classifying whole exome sequencing devices into Class 2 (special controls). The move follows a 2019 request from Helix OpCo for the de novo classification of its Helix Learning Platform, which is used for analyzing the complete coding region of an individual’s DNA. The DNA
FDA Policy/General
FDA has granted Aisa Pharma an orphan drug designation for its investigational drug AISA-021 (cilnidipine) and its use in treating systemic sclerosis (SSc), a rare and severe autoimmune disease affecting approximately 175,000 Americans. SSc has the highest mortality rate among autoimmune diseases, according to the company, and it
FDA Policy/General
Federal Register notice: FDA is classifying blood collection devices for cell-free nucleic acids into Class 2. The action is based on a Streck Inc. request for de novo classification of its Cell-Free DNA BCT, which the agency is identifying as intended for medical purposes to collect, store, transport,
FDA Policy/General
Federal Register notice: FDA is classifying endoscopic pancreatic debridement devices into Class 2 (special controls). The action is based on a de novo classification request submitted by Interscope, Inc. for its EndoRotor device. The device is designed to endoscopically remove necrotic tissue from a walled-off pancreatic necrosis cavity. The
FDA Policy/General
Federal Register notice: FDA is seeking comments on an information collection revision entitled “Pharmaceutical Distribution Supply Chain; Drug Supply Chain Security.” The collection helps support agency regulations that govern the pharmaceutical distribution supply chain. The agency says it has revised Form FDA 3911 (notification of illegitimate products) and the instructions
FDA Policy/General
Federal Register notice: FDA is making available a draft guidance entitled “Incorporating Voluntary Patient Preference Information over the Total Product Life Cycle.” The document discusses the principal concepts that sponsors and other interested parties should consider when choosing to collect and submit patient preference information (PPI). The agency says the
FDA Policy/General
Federal Register notice: FDA is announcing a 10/10 Cardiovascular and Renal Drugs Advisory Committee meeting to review a Stealth BioTherapeutics NDA for elamipretide hydrochloride injection, indicated for treating Barth syndrome. The submission is based on data from the SPIBA-001 Phase 3 Natural History Control Study and additional supporting
FDA Policy/General
Federal Register notice: FDA has submitted to OMB an information collection reinstatement entitled “Yale-Mayo Clinic Centers of Excellence in Regulatory Science and Innovation (CERSI) B12 Pediatric Device Survey.” The collection supports a planned survey of industry and other key stakeholders in the medical device ecosystem to identify the barriers
FDA Policy/General
Federal Register notice: FDA has determined that Pfizer’s Flagyl (metronidazole) tablets, 250mg and 500mg, were not withdrawn due to safety or effectiveness reasons. The determination permits the agency to approve ANDAs that reference the product as long as they meet relevant legal and regulatory requirements. The product is indicated
FDA Policy/General
Federal Register notice: FDA is announcing the revocation of a 2020 emergency use authorization (EUA) granted to Roche Molecular Systems for the cobas SARS-CoV–2 & Influenza A/B nucleic acid test for use on the cobas Liat System. The company has told the agency that it has ceased
FDA Policy/General
Federal Register notice: FDA is classifying intervertebral body graft containment devices into Class 2 (special controls). The action is based on a 2020 Spineology de novo classification request for the Spineology Interbody Fusion System. The classification describes the non-rigid implant as designed to contain the bone graft within its
FDA Policy/General
Federal Register notice: FDA is classifying neuromuscular tongue muscle stimulators and their use for reducing snoring and obstructive sleep apnea into Class 2 (special controls). The action is based on a 2020 de novo classification request from Signifier Medical Technologies for its eXciteOSA device. As part of the classification, FDA
FDA Policy/General
Federal Register notice: FDA is classifying certain digital therapy devices for attention deficit hyperactivity disorder (ADHD) into Class 2. The action is based on a 2020 de novo classification request by Akili Interactive Labs for its EndeavorRx device. The classification identifies these devices as software intended to provide therapy for
FDA Policy/General
Federal Register notice: FDA is announcing a minor technical modification to an alternative option that permits quarterly manufacturer reporting of certain device malfunction medical device reports in summary form — Voluntary Malfunction Summary Reporting Program. The modification applies to voluntary summary reports for reportable malfunction events that device makers become aware