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
Biologics
FDA commissioner Stephen Hahn and CBER director Peter Marks say the available data “continue to support the use of two specified doses of each authorized [Covid-19] vaccine at specified intervals.” Hahn and Marks issued a joint statement to counter mass media articles and opinion pieces, such as this one
FDA Policy/General
FDA has posted its latest batch of Warning Letters. They can be accessed by clicking on the link following each letter. Coco’s Holistic Specialties & Apothecary (1/4): FDA recently reviewed the firm’s Web site (https://cocosholisticspecialties.org) and determined that it is marketing unapproved and misbranded products
Devices
FDA has published a guidance, Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program, with an overview of the mechanisms available to submitters to request feedback from or a meeting with FDA on various types of potential or planned medical device submissions. The document says the
FDA Policy/General
Federal Register notice: FDA is seeking comments on an information collection extension entitled “Class II Special Controls Guidance Document: Labeling for Natural Rubber Latex Condoms — 21 CFR 884.5300” (OMB Control Number 0910-0633). To view the notice, click here.
Drugs
FDA has published a draft guidance, Human Gene Therapy for Neurodegenerative Diseases, with recommendations for sponsors developing human gene therapy products for neurodegenerative diseases affecting adult and pediatric patients. The document defines neurogenerative diseases as a heterogeneous group of disorders characterized by progressive degeneration of the structure and function of
Drugs
FDA has lifted its partial hold on a Marker Therapeutics Phase 2 trial investigating the safety and efficacy of MAT-401, the company’s lead multi-tumor-associated antigen-specific T cell product candidate for treating post-transplant acute myeloid leukemia (AML). The company says the trial is evaluating the
Drugs
FDA says its review of a Web site and Facebook site maintained by Reddy Naturals, Kennesaw, GA, indicated that the company is selling several products that are considered unapproved new drugs under the Federal Food, Drug, and Cosmetic Act. A 12/18 Warning Letter quotes extensively from the company Web
Drugs
FDA has released the FDA-483 issued following a 3/16-3/20/20 inspection at OSO Biopharmaceuticals Manufacturing, an Albuquerque, NM, parenteral drug manufacturer. The two inspection observations were: * failing to establish procedures designed to prevent microbiological contamination of drug products purporting to be sterile; and * failure of written