FDA Policy/General
HHS has overridden FDA commissioner Stephen Hahn’s choice of who will temporarily lead the Office of Chief Counsel after chief counsel Stacy Cline Amin stepped down 1/11 (see earlier story). Hahn had announced that agency career lawyer and principal deputy chief counsel Mark Raza would serve as acting
Drugs
FDA commissioner Stephen Hahn has been asked to provide a progress report on recent steps the agency has taken to combat the opioid crisis. A 1/11 letter to Hahn from 48 state attorneys general requests an update on efforts to reduce prescription opioid abuse and accidental deaths using new
FDA Policy/General
A new FDA report identifies four regulatory science strategic initiatives for 2021 — unleashing the power of data; increasing choice and competition through innovation; empowering patients and consumers; and public health emergency preparedness and response. The Advancing Regulatory Science at FDA: Focus Areas of Regulatory Science report was developed to “identify
FDA Policy/General
Federal Register notice: FDA is requesting comments on a document entitled “Potential Approach for Defining Durations of Use for Medically Important Antimicrobial Drugs Intended for Use In or On Feed: A Concept Paper.” The paper outlines a potential framework for how sponsors of new animal drug products containing medically important
FDA Policy/General
Federal Register notice: FDA is requesting that any industry organizations interested in participating in the selection of nonvoting industry representatives to serve on CDRH’s National Mammography Quality Assurance Advisory Committee notify it in writing. To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA is seeking comments on a proposed “Collection of Information for Participation in FDA Non-Employee Fellowship and Traineeship Programs.” The collection supports FDA intramural training programs through fellowship and traineeship programs. These mandatory collection forms provide FDA with information from the non-employee to: (1) Begin
Drugs
FDA chief counsel Stacy Cline Amin is stepping down effective today after leading the agency’s legal shop for over two years. “During a time of unprecedented challenges at the FDA, Stacy has played a critical role in nearly every aspect of our Covid-19 pandemic response efforts, including record
Drugs
Fresenius Kabi USA has recalled one lot of ketorolac tromethamine injection, 30 mg/mL, 1 mL fill in a 2 mL amber vial, due to the presence of particulate matter detected in reserve sample vials. No adverse event reports have been reported with the recalled lot, according to a recall
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