Drugs
FDA has granted RedHill Biopharma a fast track designation for RHB-204 and its use as a potential first-line, stand-alone, oral treatment for pulmonary nontuberculous mycobacteria (NTM) disease caused by Mycobacterium avium Complex – a rare disease for which there is no FDA-approved first-line therapy. The company
Devices
FDA has granted Functional Neuromodulation a breakthrough device designation for the Vercise Deep Brain Stimulation (DBS) System, developed and manufactured by Boston Scientific, for treating patients 65 years and older with mild probable Alzheimer’s disease. Functional Neuromodulation says a pivotal trial is underway to evaluate the safety and efficacy
Devices
Tidepool, an open source diabetes nonprofit, has submitted a 510(k) for an automated insulin dosing app for use on the iPhone for managing Type 1 diabetes. The agency has told the company that the submission had completed FDA’s administrative acceptance review and was proceeding to substantive review as
Devices
FDA will participate in the new Pathology Innovation Collaborative Community being convened by the Medical Device Innovation Consortium (MDIC) as a regulatory science initiative aiming to facilitate innovations in pathology that may advance safety and effectiveness evaluation. The group also is to harmonize approaches to speed delivery to patients using
FDA Policy/General
Federal Register notice: FDA has made available a final guidance entitled Safer Technologies Program for Medical Devices. The document describes a new, voluntary program for certain medical devices and device-led combination products that are reasonably expected to significantly improve the safety of currently available treatments or diagnostics that target
FDA Policy/General
Federal Register notice: FDA has made available a draft guidance entitled Human Gene Therapy for Neurodegenerative Diseases. The document provides recommendations for sponsors developing human gene therapy products for neurodegenerative diseases affecting adult and pediatric patients. It defines neurogenerative diseases as a heterogeneous group of disorders characterized by progressive degeneration
Drugs
Teva says it appreciates FDA publication of the compliance policy for the quantity of bioavailability and bioequivalence samples retained under regulations. In a 1/5 comment letter, it notes that the requirement to have each reserve sample contain a sufficient quantity so that FDA can perform five times all the
Drugs
Pharmaceutical Research and Manufacturers of America (PhRMA) says that if FDA continues with a plan to post on a Web site a high-level summary of the agency’s review of REMS (risk evaluation and mitigation strategy) assessments, it should consider inviting applicants to review the summaries and discuss with
Drugs
FDA has granted priority review for AstraZeneca’s Farxiga (dapagliflozin) for treating new or worsening chronic kidney disease (CKD) in adults with and without Type 2 diabetes. The designation was based on clinical evidence from the DAPA-CKD Phase 3 trial showing Farxiga, on top of standard of care consisting
FDA Policy/General
Former CDER director Janet Woodcock, who has been on detail at the White House’s Operation Warp Speed (OWS), has moved to the Office of Commissioner to serve as principal medical advisor to the commissioner while also continuing her role with OWS. The move came at commissioner Stephen Hahn’s
FDA Policy/General
Federal Register notice: FDA is withdrawing a 12/29 Federal Register notice entitled “Fee Rates Under the Over-the-Counter Monograph User Fee Program for Fiscal Year 2021” because FDA lacked the delegated authority to issue the notice. HHS has ordered FDA to cease further collection efforts related to the
Drugs
FDA has deferred action on a Mylan/Biocon BLA for a proposed biosimilar of Genentech’s Avastin (bevacizumab). The agency accepted the BLA in 3/2020 with a planned action date of 12/27/20, according to a OneLive report. The delay reportedly came because FDA was unable to complete
Devices
FDA has cleared the CardioWise Stretch Quantifier for Endocardial Engraved Zones (SQuEEZ), an image analysis software application for cardiac computer tomography (CT) studies to assist cardiologists and radiologists in assessing function when producing a cardiac evaluation. The company says SQuEEZ is based on the ability in sequential high-resolution cardiac
Devices
FDA has published a guidance, Safer Technologies Program for Medical Devices, to introduce a new voluntary program for certain medical devices and device-led combination products that are reasonably expected to significantly improve the safety of currently available treatments or diagnostics that target an underlying disease or condition associated with
FDA Policy/General
Federal Register notice: FDA has issued an order to permanently debar former Insys Therapeutics regional sales manager Alec Burlakoff from providing services in any capacity to a person that has an approved or pending drug product application. Last year, he was convicted of engaging in multiple acts of illegal distribution
FDA Policy/General
Federal Register notice: FDA has issued an order to permanently debarring former Cumberland Distribution owner Jerrod Nichols Smith from providing services in any capacity to a person that has an approved or pending drug product application. Smith recently was convicted of violations related to wholesale drug distribution. To view the
FDA Policy/General
Federal Register notice: FDA has made available a draft guidance entitled IND Submissions for Individualized Antisense Oligonucleotide Drug Products: Administrative and Procedural Recommendations. The document is intended to help sponsors develop such products for treating severely debilitating or life-threatening genetic disease. To view the notice, click here.
Drugs
Nostrum Laboratories has recalled one lot of metformin HCl extended release tablets, USP 750 mg, because it was found to contain levels of nitrosamine impurities above FDA-approved limits. The product is indicated as an adjunct to diet and exercise to improve blood glucose control in adults with Type 2
Drugs
FDA has released the FDA-483 issued following a 9/24-10/9/20 inspection at Stokes Healthcare, a Mount Laurel, NJ, outsourcing facility doing business as Epicur Pharma. The four observations on the form were: * failing to justify deviations from written production and process control procedures; * failing to have
Drugs
FDA has published a report, “Advancing New Alternative Methodologies at FDA,” to demonstrate the significant progress it says the agency has made in laying the groundwork for integrating alternative approaches into regulatory programs. The report was developed by the agency’s Alternative Methods Working Group, building upon the Predictive Toxicology
FDA Policy/General
Federal Register notice: FDA has made available a final guidance entitled Mouse Embryo Assay for Assisted Reproduction Technology Devices. The document provides recommendations on conducting the mouse embryo assay to support premarket submissions and lot release of assisted reproduction technology devices. To view the notice, click here.
Devices
FDA has issued a safety alert about false result risks (mostly false negatives) with KorvaLabs’ Curative SARS-Cov-2 (Covid-19) test. To reduce the risk of false negative results, it is important to perform the test in accordance with its emergency use authorization and as described in the authorized