Devices
FDA has cleared an Andersen Sterilizer 510(k) for its EOGas 4 Ethylene Oxide Gas Sterilizer and associated accessories for sterilizing duodenoscopes and colonoscopes. The device is labeled for sterilizing reusable medical devices that are sensitive to moisture, heat, corrosion or radiation, the company says. It was originally cleared in
Drugs
FDA has approved a Lantheus Holdings and Progenics Pharmaceuticals supplemental NDA for Definity Room Temperature (perflutren lipid microsphere) injectable suspension, an ultrasound enhancing agent intended for use to enhance suboptimal echocardiograms. Its modified formulation allows both storage and shipment at room temperature (Definity’s previously approved formulation requires refrigerated storage)
Drugs
FDA has informed Bristol-Myers Squibb that it will not complete its review of the company’s BLA for lisocabtagene maraleucel (liso-cel) by the 11/16 PDUFA action date. The drug is indicated for treating adults with relapsed or refractory large B-cell lymphoma after at least two prior
Drugs
FDA has granted Lucira Health an Emergency Use Authorization for the first prescription molecular diagnostic test for Covid-19 that can be performed entirely at home. The Covid-19 All-In-One Test Kit can produce a positive or negative result at home within 30 minutes. The authorization was based
Drugs
Pfizer and BioNTech say they are planning to submit within days an Emergency Use Authorization request for their Covid-19 vaccine candidate BNT162b2 after a final analysis showed a vaccine efficacy rate of 95%, which was a significant improvement from the 90% reported in a preliminary analysis last week (see
FDA Policy/General
Federal Register notice: FDA is seeking comments on an information collection extension entitled “Expedited Programs for Serious Conditions — Drugs and Biologics” (OMB Control Number 0910-0765). The collection supports agency procedures designed to expedite the development, evaluation, and marketing of new therapies intended to treat persons with life-threatening and
FDA Policy/General
Federal Register notice: FDA has submitted to OMB an information collection revision entitled “Registration of Human Drug Compounding Outsourcing Facilities Under Section 503B of the Federal Food, Drug, and Cosmetic Act and Associated Fees” (OMB Control Number 0910–0776). The collection supports FDA’s policy allowing drug products compounded in
Drugs
The HHS Office of Inspector General (OIG) says it has significant concerns about companies offering or paying remuneration, and healthcare professionals (HCP) soliciting or receiving remuneration, in connection with speaker programs. “Based on our investigations and enforcement actions,” an OIG fraud alert says, “this remuneration is often offered or paid
FDA Policy/General
Federal Register notice: FDA is correcting a notice that appeared in the 1/8 Federal Register announcing the approval withdrawals for 19 NDAs from multiple applicants. That notice indicated that FDA was withdrawing R2 Pharma’s NDA 202342, esomeprazole strontium delayed-release capsules. Because of clerical errors in the agency’
Devices
Sens. Charles Grassley (R-IA) and Elizabeth Warren (D-MA) have asked FDA to issue its proposed rule on over-the-counter hearing aids as quickly as possible. In an 11/13 letter, the senators say that since President Donald Trump signed the Over-the-Counter Hearing Aid Act into
Drugs
An 11/13 petition filed by Epstein Becker Green on behalf of an unnamed client asks FDA to require that adequate cardiovascular safety and all-cause mortality data be submitted to the agency for review before approving roxadustat for treating anemia in patients with chronic kidney disease. The petition also
Drugs
The American Geriatrics Society (AGS) says FDA should consistently use the word “older” in a draft guidance on geriatric information in human prescription drug and biological product labeling rather than “elderly” or any similar term. In an 11/9 comment letter, AGS says that terms like “elderly,” “elders,” “the aged,
Devices
FDA says its review of data and information from several sources indicates that there generally are more benefits than risks to patient safety and health related to software functions excluded by the 21st Century Cures Act from the definition of a medical device. The agency’s 2020 report on risks
Drugs
FDA has accepted for review a BLA submitted by Samsung Bioepis and Biogen for their SB11, a proposed biosimilar referencing Genentech’s Lucentis (ranibizumab). Lucentis is an anti-VEGF (vascular endothelial growth factor) therapy for retinal vascular disorders. Samsung Bioepsis said in 11/2019 that it had entered into a
Biologics
Omeros has completed a rolling BLA submission for narsoplimab for treating hematopoietic stem cell transplant-associated thrombotic microangiopathy (HSCT-TMA). The monoclonal antibody targets mannan-binding lectin-associated serine protease-2 (MASP-2), the company says. “Importantly,” it says, “inhibition of MASP-2 does not appear to interfere with the
FDA Policy/General
Federal Register notice: FDA has made available a draft guidance entitled Electromagnetic Compatibility of Medical Devices. The document describes relevant information that should be provided in device premarket submissions. To view the notice, click here.
Drugs
CDER researchers say they have determined that adding a cyclin-dependent kinase (CDK) 4/6 inhibitor to a hormonal agent appears to show a consistent benefit for all subgroups analyzed in a study of hormone receptor-positive, HER2-negative metastatic breast cancer. An agency online Regulatory Science Impact Story says
Drugs
FDA has announced a 1/26 virtual workshop to communicate current regulatory thinking and considerations on non-clinical assays for comparative immunogenicity risk assessment for generic peptide products. The agency says the workshop will discuss the following four topics: * In silico methods to assess binding affinity to major histocompatibility complex
Drugs
FDA commissioner Stephen Hahn says that the agency is increasing transparency for Covid-19 emergency use authorizations (EUAs) by posting CDER and CBER reviews of the scientific data and information supporting the issuance, revision, or revocation of EUAs for all drug and biological products, including vaccines. Such a move was
Drugs
Pharmaceutical Research and Manufacturers of America (PhRMA) has added a new chapter, “Enhancing Diversity in Clinical Trial Participation,” to its Principles on Conduct of Clinical Trials and Communication of Clinical Trial Results. A PhRMA statement says the revised principles take effect 4/14/21. With the revision, the statement says,
Drugs
FDA has posted safety-related labeling changes for five biologics. The change for Merck’s Keytruda (pembrolizumab) involves the potential for infusion reactions added to the Warning and Precautions section of the labeling. Changes were also posted for EMD Serono/Pfizer’s Bevencio (avelumab), Lilly’s Erbitux (cetuximab), AstraZeneca’s
Drugs
A 2/3-2/12 FDA inspection at Family Pharmacy of Statesville, Statesville, NC, found multiple drug compounding violations. An 11/6 Warning Letter discusses violations relating to compounded drug products under the Federal Food, Drug, and Cosmetics Act, failing to meet the conditions of Section 503A, adulterated drug products,