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…
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on the development of oncology drugs and biologics, posting a final guidance on optimizing cancer drug doses and a draft guidance on developing…
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…
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.…
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…
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.…
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…
The CDER Office of Pharmaceutical Quality (OPQ) Experiential Learning Site Visit Program (ELSVP) is inviting pharmaceutical companies interested in participating to submit a site visit proposal. Source: Drug Industry Daily
This week, the FDA published final guidance on optimizing the dosage of drugs and biological products for oncologic diseases and draft guidance for developing drug and biological products for bladder…
CDER’s Office of Surveillance and Epidemiology (OSE) made significantly more use of AI and machine learning tools in 2023 to reduce the demands of manual reviews, according to OSE’s latest…