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the FDA published final guidance on optimizing the dosage of drugs and biological products for oncologic diseases and draft guidance for developing drug and biological products for bladder…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…
The FDA has announced the availability of the International Council of Harmonisation (ICH) final guidance and questions and answers on drug interaction studies and ICH has issued a final guideline…
Serious issues with Medtronic’s nerve monitoring system and Smiths Medical’s ambulatory infusion pumps have prompted software corrections from the two devicemakers, with the FDA assigning the recalls the greatest level…
Sponsors of adaptive AI-enabled medical devices seeking FDA approval should consider submitting a predetermined change control plan (PCCP), according to regulatory attorney Eric Henry of King & Spalding. Source: Drug…
This edition of Quick Notes features announcements of a Recursion and Exscientia merger, Boehringer Ingelheim acquisition of Nerio Therapeutics, BioNTech’s decision to discontinue working with Genmab on acasunlimab, the sale of…
CDRH has developed a discussion paper, “Health Equity for Medical Devices,” to gather input from the public on advancing health equity in the context of medical devices. Source: Drug Industry…
Mirati Therapeutics has been issued an untitled letter by the FDA for making misleading online claims about the efficacy of its non-small cell lung cancer (NSCLC) drug Krazati (adagrasib), violations…