Drugs
Pfizer says new data on its Covid-19 oral antiviral drug Paxlovid (nirmatrelvir tablets and ritonavir tablets) show the drug significantly reduced the risk of hospitalization or death for any cause by 89% compared to placebo in non-hospitalized, high-risk adult patients with Covid and treated within three days
Biologics
A 7/8-7/19 FDA inspection at Cooper Institute for Advanced Reproductive Medicine, Houston, TX, found significant deviations from the regulations for human cells, tissues, and cellular and tissue-based products. A 12/15 Warning Letter says specific deviations were: * failing to test a specimen from an anonymous or
Drugs
FDA has published an immediately effective guidance, Policy for Certain REMS Requirements During the Tocilizumab Shortage Related to the Covid-19 Public Health Emergency, communicating its temporary policy for certain REMS (risk evaluation and mitigation strategies) requirements for tocilizumab (Genentech’s Actemra) due to the shortage related to the Covid-
Devices
FDA has approved Svelte Medical Systems’ Slender IDS fixed-wire and Direct RX rapid-exchange drug-eluting stent systems to treat coronary artery disease. The company says the two systems, incorporating the same stent, bioresorbable drug coating, and balloon technologies, achieved 1.5% clinically-driven target lesion revascularization at one
FDA Policy/General
Federal Register notice: FDA is making available a draft guidance entitled Bowel Cleansing for Colonoscopy: Efficacy and Safety Considerations for Developing New Products. The document provides FDA’s current thinking on the necessary attributes of patients for enrollment in clinical trials, efficacy assessments, and safety assessments. To view the notice,
FDA Policy/General
Federal Register notice: FDA is making available a final guidance entitled Development of Anti-Infective Drug Products for the Pediatric Population. The document addresses enrollment strategies, extrapolation of efficacy, safety database, and other considerations to help pediatric anti-infective drug development. To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA is making available a final guidance for industry entitled Q3C (R8) Impurities: Guidance for Residual Solvents. The International Council for Harmonization document provides recommendations for permitted daily exposures (PDEs) for three additional residual solvents: 2-methyltetrahydrofuran, cyclopentylmethyl ether, and tert-butyl alcohol. The agency says the
Drugs
A just released U.S. House Oversight and Reform Committee staff report has found that drug companies have “raised prices relentlessly for decades while manipulating the patent system and other laws to delay competition from lower-priced generics.” The report, which examined 12 drugs from 10 companies, said they targeted
Devices
FDA has approved an Urotronic PMA for Optilume Urethral Drug Coated Balloon for use in male urethral strictures. Optilume is designed as an alternative to traditional endoscopic stricture treatments. It dialates the urethral lumen and delivers paclitaxel directly to the stricture, significantly reducing the incidence of stricture recurrence, according to
Devices
FDA’s Medical Devices Advisory Committee’s Neurological Devices Panel has voted 7 to 3 that a BrainsGate PMA for its Ischemic Stroke System did not demonstrate the device’s benefits outweigh its risks. The company is seeking an indication for increasing cerebral blood flow and to reduce disability in
FDA Policy/General
Federal Register notice: FDA is making available a draft guidance entitled Chronic Rhinosinusitis with Nasal Polyps: Developing Drugs for Treatment. The document addresses FDA’s current recommendations regarding trial design, safety, and efficacy considerations. To view the notice, click here.
Drugs
FDA has placed clinical holds on Merck INDs for the oral and implant formulations of islatravir (MK-8591) for HIV-1 pre-exposure prophylaxis (PrEP); the injectable formulation of islatravir for HIV-1 treatment and prophylaxis; and the oral doravirine/islatravir (DOR/ISL) forulation for HIV-1 once-daily treatment.
FDA Policy/General
Info Collection Revision on Drug Reporting 12/10/2021 Federal Register notice: FDA has submitted to OMB an information collection revision for a guidance entitled “Postmarketing Adverse Experience Reporting and Recordkeeping for Drug and Biologics Products” (OMB Control Number 0910-0230). The collection supports statutory provisions regarding the monitoring of
FDA Policy/General
DEVICES FDA has approved a FujiFilm Medical Systems PMA for the Digital Breast Tomosynthesis (DBT), as an optional software upgrade for its ASPIRE Cristalle digital mammography system. “With the DBT software option, the x-ray tube moves through an arc around the breast, acquiring a series of low-dose image
FDA Policy/General
Momenta Pharmaceuticals and Mylan have entered into a collaboration agreement to develop, manufacture and commercialize six of Momenta’s current biosimilar candidates, including a version of Bristol-Myers Squibb’s Orencia (abatacept), indicated for treating rheumatoid arthritis. Under the agreement, Mylan will make an upfront $45 million cash payment to
FDA Policy/General
Federal Register notice: FDA is reopening the comment period on a draft guidance entitled Real-World Data: Assessing Electronic Health Records and Medical Claims Data To Support Regulatory Decision-Making for Drug and Biological Products. Comments can be submitted until 1/24/2022. To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA has submitted to OMB an information collection revision entitled “Labeling Requirements for Prescription Drugs” (OMB Control Number 0910-0572). The collection supports FDA regulations governing the labeling of prescription drugs, and sets forth both general and specific content and format requirements. To view the notice, click
FDA Policy/General
Federal Register notice: FDA has made available a final guidance entitled CMC Postapproval Manufacturing Changes for Specified Biological Products to Be Documented in Annual Reports. The guidance outlines the types of changes to be documented in annual reports: changes that FDA generally considers to have a minimal potential to have
Drugs
FDA has published a draft guidance entitled Cover Letter Attachments for Controlled Correspondences and ANDA Submissions. The document discusses optional attachments that can be used when preparing cover letters that accompany controlled correspondence to CDER’s Office of Generic Drugs, as well as original ANDAs, amendments to ANDAs, and supplements
Devices
CDRH has issued a discussion paper, “3D Printing Medical Devices at the Point of Care,” that proposes potential point-of-care (PoC) manufacturing scenarios for public comment. The paper identifies challenges presented by 3D-printed devices at PoC and offers a potential approach for regulatory oversight under various scenarios to
Drugs
FDA has posted an International Council for Harmonization guidance entitled Q3C(R8) Impurities: Guidance for Residual Solvents. The document provides recommendations for permitted daily exposures for three residual solvents: (1) 2-methyltetrahydrofuran, (2) cyclopentyl methyl ether, and (3) tert-butyl alcohol. It is intended to recommend acceptable amounts for these
Devices
Medtronic’s Covidien unit has recalled its Puritan Bennett 980 Ventilator Series System due to a manufacturing assembly error where a capacitor within the ventilator was assembled incorrectly, which may cause the device to become inoperable during use. Customers have been told to immediately discontinue use of the affected ventilators