Drugs
Pfizer says it gained an expanded indication in late December for Ibrance (palbociclib) to include its use in combination with an aromatase inhibitor (AI) for treating HR+/HER2- metastatic breast cancer, regardless of menopausal status — the only CDK 4/6 inhibitor with this indication. “The approval expands on Ibrance’s
Devices
FDA has cleared a Clarius Mobile Health 510(k) for its new MSK (musculoskeletal) AI model, which automatically identifies and measures tendons in the foot, ankle, and knee using artificial intelligence (AI). The company says the new device will be available soon with the company’s Clarius L7 HD3 and
Devices
Xenex Disinfection Services has filed a de novo petition for its LightStrike+ ultraviolet (UV) room disinfection technology. The company’s device uses a xenon lamp to create broad spectrum UV light intended to destroy pathogens on surfaces in healthcare facilities. It has been marketed during the Covid-19 emergency under
Devices
FDA says a 6/28-7/8/22 inspection at RightEye, LLC, in Bethesda, MD, determined the firm is promoting its RightEye Vision System, a Class 2 nystagmograph medical device, for off-label uses to improve vision problems and measure and analyze eye movements for “neurological disorders.” A just-released
Drugs
A 4/11-4/27/22 FDA inspection at Adept Life Science in Chandler, AZ, found “serious violations” of the Federal Food, Drug, and Cosmetic Act and applicable regulations as they apply to dietary supplements. A 1/24 Warning Letter gives eight examples of current good manufacturing practice (CGMP) violations
Drugs
FDA’s 2022 GDUFA Science and Research Report says that during FY 2022 FDA awarded eight new research contracts and seven new grants (not including supplements to existing projects) for innovative extramural research projects relevant to generic drugs. The report says the agency also used its laboratories and computer systems
Drugs
Two FDAers from the CDER Office of Translational Sciences say there is an opportunity to leverage innovations in clinical pharmacology and related disciplines to improve the efficiency of biosimilar development and approval. Writing in an editorial introducing a themed issue of Clinical Pharmacology & Therapeutics, the authors say one way
Drugs
FDA has published a draft guidance, Considerations for the Design and Conduct of Externally Controlled Trials for Drug and Biological Products, with recommendations for sponsors and investigators considering the use of externally controlled clinical trials to provide evidence of the safety and effectiveness of a drug product. The document addresses
Drugs
Attorneys James Boiani and Delia Deschaine (Epstein Becker Green) say FDA’s recent Federal Register notice on orphan drug exclusivity (see earlier story) “is a remarkably direct rebuke” of the an 11th Circuit Court of Appeals decision in Catalyst Pharms, “especially in light of Congress’ rejection of legislation that would
Biologics
CBER has published its 2023 guidance agenda listing 11 guidances in two categories that it is considering for development during the current calendar year. The agenda lists six possible guidances under Blood and Blood Products and five guidances under Tissues and Advanced Therapies.
FDA Policy/General
The Biden Administration has announced that it will end the current Covid-19 public health emergency (PHE) declaration and national emergency declaration, which were declared in 2020, on 5/11. FDA says a future Federal Register notice will be published on how the decision to end the PHE will affect
Biologics
After more than 22 years at FDA, CBER Office of Tissues and Advanced Therapies director Wilson Bryan is retiring in March. Bryan is a neurologist by training and graduated from the University of Chicago Pritzker School of Medicine. Before coming to FDA, he served on the neurology faculty at the
FDA Policy/General
FDA commissioner Robert Califf announced 1/31 a new “transformative vision” for the agency’s human foods program and the Office of Regulatory Affairs that addresses recommendations and findings from a 12/2022 external evaluation by the Reagan-Udall Foundation that the agency requested. Califf says the new proposed structures
FDA Policy/General
Federal Register notice: FDA is announcing the issuance of two Emergency Use Authorizations for diagnostic devices in response to the ongoing Monkeypox outbreak. One EUA was granted to Becton Dickinson for its Viasure Monkeypox virus Real Time PCR Reagents for the BD MAX System, and the other to DiaCarta, Inc.
FDA Policy/General
Federal Register notice: FDA is classifying software for optical camera-based measurements of pulse rate, heart rate, breathing rate, and/or respiratory rate into Class 2 (special controls). Such devices use software algorithms to analyze video signals and estimate pulse rate, heart rate, breathing rate, and/or respiratory rate, and
Devices
FDA has classified as Class 1 a Smiths Medical recall associated with a 12/2022 company-issued “urgent medical device correction” letter identifying two potential issues with CADD Infusion System Infusion Sets due to lack of delivery or underdelivery and false “no disposable attached (NDA)” alarms. A recall notice details
Devices
FDA has posted a final guidance entitled “Surveying, Leveling, and Alignment Laser Products.” The document says that such laser products are used for “determining and delineating the form, extent, or position of a point, body, or area by taking angular measurement; positioning or adjusting parts in proper relation to one
Devices
FDA has classified as Class 1 a Medtronic recall of its Mahurkar 13.5Fr high-flow, dual lumen acute dialysis catheter based on a potential leaking condition within the device hub. “During treatment, this leak could result in mixing of the arterial and venous blood, lead to increased recirculation and
Drugs
FDA is making available a draft guidance entitled “Acromegaly: Developing Drugs for Treatment.” The document provides recommendations about the clinical development of such drugs, and the agency says it is intended to serve as the basis for continued discussions with its Division of General Endocrinology, pharmaceutical sponsors, the academic community,
Drugs
The U.S. District Court for Southern Florida 1/20 entered a consent decree of permanent injunction against LGM Pharma and two of the company's executives, CEO Prasad Raje and quality and regulatory affairs senior vice president Shailesh Vengurlekar, to bring the company into CGMP compliance. LGM introduced
Drugs
FDA has extended by three months its review of an Argenx BLA for subcutaneous efgartigimod for treating adult patients with generalized myasthenia gravis. The revised user fee review action target date is 6/20. The agency told the company that recently submitted information constituted a major amendment and requires a
FDA Policy/General
CDER and CBER say that beginning 2/13 they will restart limited in-person, face-to-face industry meetings. It was just a matter of time for in-person industry meetings to restart after FDA commissioner Robert Califf announced late last year that FDA staff this year would be transitioning