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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. Read More
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the FDA published final guidance on optimizing the dosage of drugs and biological products for oncologic diseases and draft guidance for developing drug and biological products for bladder cancer. The agency also issued notice of a public workshop on pediatric patient diversity in therapeutics development, a request for comments on information collection associated with a proposed study titled “Healthcare Provider Survey of Topics Related to Prescription Drug Promotion and an OPQ request for proposals for staff site visits. Read More
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 annual report. Read More
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 on bioequivalence (BE) studies. Read More
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 of concern. Read More
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. Read More
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 Mallinckrodt’s Therakos business, expansion of Daiichi Sankyo’s and Merck’s collaboration agreement, and Sangamo’s development deal with Genentech. Read More
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. Read More
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 considered especially egregious by the agency due to the condition’s serious and devastating nature. Read More
The FDA has determined that the phase 3 SIERRA trial conducted by Actinium Pharmaceuticals is not adequate to support a BLA filing for Iomab-B to treat patients with active relapsed or refractory acute myeloid leukemia, the company recently announced. 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 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
In this edition of Quick Notes, we provide a look at the first dissolvable oral contraceptive, good news for Pfizer’s hemophilia A gene therapy, approval of a new treatment for multiple myeloma and a clinical hold on a Type 1 diabetes therapy. Read More