Drugs
The U.S. Food and Drug Administration (FDA) has accepted a Boehringer Ingelheim and Eli Lilly supplemental NDA for Jardiance (empagliflozin) for reducing the risk of cardiovascular death and hospitalization for heart failure and slowing kidney function decline in adults with chronic heart failure with reduced ejection fraction, including those
Devices
Boston Scientific has recalled all unused inventory of its Lotus Edge Aortic Valve System due to “complexities” associated with the product delivery system, according to a recall notice. The recall is related specifically to the delivery system, and the valve “continues to achieve positive and clinically effective performance post-implant,
FDA Policy/General
Federal Register notice: FDA has determined that 20 drug products (detailed below) were not withdrawn from sale for reasons of safety or effectiveness. The determination means that the agency will continue to approve ANDAs that refer to the products as long as they meet relevant legal and regulatory requirements. Affected
FDA Policy/General
Federal Register notice: FDA has reopened the comment period for a notice that appeared in the 7/31/2020 Federal Register in which FDA identified certain bulk drug substances (active pharmaceutical ingredients) that it has considered and proposes to include or not include on the list of bulk drug substances
Drugs
FDA says that all 53 new molecular entity approvals (see earlier story) in 2020 were acted on by or before their user fee goal dates, and most were approved in the U.S. before any other country in the world. In a 1/8 annual approvals report, the agency says
FDA Policy/General
Federal Register notice: FDA is seeking comments on an information collection extension entitled “FDA Recall Regulations — 21 CFR Part 7” (OMB Control Number 0910-0249). The collection helps support implementation of Section 701 of the Federal Food, Drug, and Cosmetic Act (21 USC 371) pertaining to product recalls, and regulations
Drugs
FDA has placed a clinical hold on a Neoleukin Therapeutics Phase1 clinical trial of its immunotherapeutic candidate, NL-201. The agency told the company that it needs to develop a new assay that more precisely measures the amount of protein being administered and demonstrate with this assay that dose and
Drugs
CDER has announced that a planned Office of Generic Drugs (OGD) reorganization has been approved and will be implemented later this year. The new structure is intended to strengthen OGD’s operations and allow it to meet generic drug review expectations, according to an agency release. Changes include establishing a
FDA Policy/General
Federal Register notice: FDA is requesting that any consumer organizations interested in participating in the selection of voting and nonvoting consumer representatives to serve on its advisory committees or panels notify FDA in writing. FDA is also requesting nominations for voting and nonvoting consumer representatives to serve on advisory committees
Devices
FDA is alerting clinical laboratory staff and health care providers about the potential impact of viral mutations, including an emerging variant from the United Kingdom known as the B.1.1.7 variant, on authorized Covid-19 molecular tests, and that false negative results can occur with any molecular test
Drugs
FDA is continuing its review of a Bristol-Myers Squibb (BMS) BLA for lisocabtagene maraleucel (liso-cel), indicated for treating adults with relapsed or refractory large B-cell lymphoma after at least two prior therapies, following the completion of an inspection at third-party manufacturer Lonza. In November, the agency
Drugs
FDA has granted Gemini Therapeutics a fast track designation for GEM103, an investigational treatment for dry, age-related macular degeneration (AMD). Gemini says it is evaluating the recombinant, human complement factor H (CFH) for its ability to address multiple AMD pathobiologies in genetically-defined subsets of AMD patients caused by
FDA Policy/General
Federal Register notice: FDA has issued an order to permanently debar former Insys Therapeutics regional sales manager Joseph A. Rowan 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 a conspiracy whereby Insys
FDA Policy/General
Federal Register notice: FDA has issued an order to permanently debar former Insys Therapeutics regional sales manager Sunrise Lee from providing services in any capacity to a person that has an approved or pending drug product application. Last year, she was convicted of engaging in a conspiracy whereby Insys employees
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