Devices
FDA says the Medtronic 2/26 recall of the instructions for use and patient manual for its HeartWare HVAD (HeartWare Ventricular Assist Device) system is Class 1. An agency announcement says Medtronic recalled the system to provide updated instructions for use and patient manual due to safety issues with the
Devices
FDA has approved a Johnson & Johnson Vision PMA for its Acuvue Abiliti Overnight Therapeutic Lenses, the first orthokeratology contact lens for managing myopia. Approval was based on data demonstrating that the lenses can be a safe and effective treatment option to manage myopia, according to the company. They are
Devices
FDA has cleared a Desktop Health 510(k) for its Flexcera Base, a proprietary resin for use in 3D fabrication of dental prosthetics. Flexcera was developed with the strength of ceramic coupled with long-chain chemistry to ensure optimal denture properties, the company says. “When used exclusively with EnvisionTEC 3D
FDA Policy/General
Federal Register notice: FDA has made available a final guidance entitled Q12 Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management. The document provides a framework to facilitate the management of post-approval chemistry, manufacturing, and controls changes for new and marketed pharmaceutical drug substances and drug products, including chemical
Drugs
FDA has published a guidance, Q12 Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management: Annexes, providing a framework to facilitate the management of postapproval chemistry, manufacturing, and controls changes more predictably and efficiently. The document, approved by the International Council for Harmonization, discusses how to identify the elements in
Drugs
FDA has published an International Council for Harmonization guidance, M9 Biopharmaceutics Classification System-Based Biowaivers, describing the biopharmaceutics classification system (BCS)-based biowaivers approach intended to reduce the need for in vivo bioequivalence studies. The document says in vivo bioequivalence studies may be exempted if an assumption of equivalence in
FDA Policy/General
Federal Register notice: FDA is withdrawing approval of 12 ANDAs from multiple applicants after they notified the agency in writing that the drug products were no longer marketed and requested they be withdrawn. To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA has made available a final guidance entitled Qualified Infectious Disease Product Designation — Questions and Answers. The document is intended to provide a resource for information on FDA’s policies and procedures related to the designation of a qualified infectious disease product. To view the notice, click
FDA Policy/General
Federal Register notice: FDA is making available a final guidance entitled Covid-19: Developing Drugs and Biological Products for Treatment or Prevention. The document revises and replaces the final guidance of the same name issued on 5/11/2020. Revisions were made to address the evolving landscape of Covid-19
Drugs
Rocket Pharmaceuticals says it is pausing its RP-A501 Danon Disease program for additional risk mitigation requested by FDA. The company says the agency asked it to pause patient dosing and modify the protocol and other supporting documents with revised guidelines for patient selection and management. Rocket says it expects
Devices
FDA says the Web site maintained by Anytime Covid Test LLC, Boynton Beach, FL, indicates the firm is marketing a direct-to-consumer Covid-19 test kit that is legally considered a medical device. A just-released 4/13 Warning Letter says the kit is being offered without marketing approval,
FDA Policy/General
Former FDA senior advisor for science innovation and policy Vicki Seyfert-Margolis has been named to the Penrose TherapeuTx scientific advisory board. Penrose says it focuses on developing innovative small-molecule therapies to treat advanced cancers. In addition to her tenure at FDA, Seyfert-Margolis also has extensive experience at
Drugs
Novo Nordisk has recalled 1,468 product samples for Levemir (insulin detemir), Tresiba (insulin degludec), Fiasp (insulin aspart), Novolog (insulin aspart) and Xultophy (insulin degludec and liraglutide injection) because they were stored at temperatures below storage requirements. “If product samples are exposed to temperatures below 32°F, it could cause
Drugs
FDA has released for public comment changes proposed to Appendix 2 of the International Council for Harmonization Q3D(R2) Guideline for Elemental Impurities. The document says there are four extracts from the guideline appendices with proposed revisions.
Devices
FDA has awarded breakthrough device status to Avenda Health for a male “lumpectomy” product being developed to treat prostate cancer in-office. The company says its focal therapy system uses patient-specific information and artificial intelligence to deliver a precise and personalized treatment targeting only the tumor. Under the breakthrough
Biologics
AstraZeneca has submitted a BLA for tezepelumab, a potential first-in-class medicine for treating severe asthma. The submission is supported by data from the PATHFINDER clinical program including the pivotal NAVIGATOR Phase 3 trial, which demonstrated a statistically significant and clinically meaningful reduction in the annualized asthma exacerbation rate
FDA Policy/General
Federal Register notice: FDA is seeking comments on an information collection revision entitled “Registration of Producers of Drugs and Listing of Drugs in Commercial Distribution — 21 CFR Part 207” (OMB Control Number 0910-0045). The collection supports agency regulations implementing registration and listing provisions that set forth the scope, applicability,
Biologics
FDA has announced a 6/10 Vaccines and Related Biological Products Advisory Committee meeting to discuss Covid-19 vaccines and their use in the pediatric population. During the meeting, the agency will provide a status update on its approach to emergency use authorization (EUA) for Covid-19 vaccines intended for
Drugs
After winning an appeal at FDA last month to remove clinical trial requirements that led to a clinical hold on a study designed to assess the psychological effects of MDMA-assisted psychotherapy, the Multidisciplinary Association for Psychedelic Studies (MAPS) has formally requested that the agency remove the hold. MDMA is
Drugs
Bayer is reporting positive data from a second Phase 3 study (FIGARO-DKD) that evaluated the safety and efficacy of finerenone versus placebo when added to standard of care in patients with chronic kidney disease (CKD) and Type 2 diabetes. FIGARO-DKD met its primary endpoint, demonstrating that finerenone significantly
Drugs
Liquidia has resubmitted its NDA for LIQ861 for treating pulmonary arterial hypertension. In 11/2020, FDA issued a complete response letter indicating that the application was incomplete and not ready for approval in its present form. At the time, the company said FDA indicated a need for additional information and
Drugs
FDA has released two 2019 Form FDA-483s after inspecting two Hennepin County Medical Center (Minneapolis, MN) clinical investigators who were cited for study violations. The first FDA-483 went to sponsor investigator Lauren Klein, who was cited for failing to submit an IND to FDA for conducting a clinical