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Ensuring that laws such as the Inflation Reduction Act (IRA) do not have unexpected consequences or diminish patient-centric innovation requires a clear-eyed view of the way that legislation operates in the real world, the Biotechnology Innovation Organization (BIO) said in response to two studies conducted by Bentley University. Read More
This excerpt is from the management report titled “Managing Data and Documentation for FDA Inspections and Remote Assessments,” based on a webinar from FDAnews, a WCG Clinical company. The presenter was David Chesney, a former director of the FDA’s San Francisco District Office who is now principal and general manager of DL Chesney Consulting. Read More
A recent FDA Warning Letter illustrates to sponsors the importance of properly managing monitoring responsibilities and having a thorough site activation process. In this article, we’ll examine the letter received by the sponsor of a multisite trial of a device for preventing recurrent ischemic stroke and discuss how problems could have been avoided in the first place. Read More
Abiomed has recalled certain Impella CP with SmartAssist heart pumps after nine devices in a single lot failed a company inspection — but were inadvertently released to customers — the FDA announced. Read More
After a bumpy road to approval, the FDA has approved ARS Pharmaceuticals’ neffy (epinephrine nasal spray) for the emergency treatment of Type I allergic reactions, including those that are life-threatening (anaphylaxis), in adult and pediatric patients who weigh at least 66 pounds. Read More
This edition of Quick Notes features clearances for a mini robotic system, peripheral arterial disease and peripheral vascular disease testing devices, testing assays for the evaluation of monoclonal gammopathy and breakthrough device designation for a posterior cervical system for treatment of the cervical and upper thoracic spine. Read More
The FDA has issued two new guidances on the development of oncology drugs and biologics, posting a final guidance on optimizing cancer drug doses and a draft guidance on developing drugs specifically for Bacillus Calmette-Guérin-unresponsive nonmuscle invasive bladder cancer. Read More
A study of trends in prescriptions dispensed at retail pharmacies for semaglutide showed a 442 percent increase in fills between January 2021 and December 2023 — increasing from 659,000 to 2,270,564 during that time period, according to a recent study. Read More
CMS has issued a final procedural notice outlining a Medicare coverage pathway — Transitional Coverage for Emerging Technologies (TCET) — for certain FDA Breakthrough Devices to be covered under Medicare. Read More
During the second session of the 118th Congress, FDAnews will track important pending legislation, that has been acted on by Dec. 31, 2023 to keep you updated on laws and regulations that could impact your business. Read More
Eli Lilly announced positive results from a phase 3 clinical trial evaluating the safety and efficacy of tirzepatide injection in adults with heart failure with preserved ejection fraction and obesity. Read More
The FDA has provided a case study of how CDER used machine learning to identify a suitable patient population for a COVID-19 treatment that was approved under the emergency use authorization (EUA). Read More