FDA OTP Events, Meetings, and Workshops (Catapult’s regulatory round-up – July 2024)
The Office of Therapeutic Products (OTP) hosts a variety of events to share information about OTP-regulated products and bring together important stakeholders to discuss the development and advancement of these products. Please find event details below.
- FDA | NIH : Regulatory Do’s and Don’ts: Tips from FDA – 4 September 2024. This webinar is intended for early-stage companies (small businesses) new to the regulatory landscape at the FDA. It aims to provide an overview on resources and programs that FDA has developed across Center for Biologics Evaluation and Research (CBER), CDER, and Center for Devices and Radiological Health (CDRH) that can help academic life-science accelerators and early-stage, oncology-related companies, develop new anticancer-therapeutics, devices, and diagnostics.
- OTP Town Hall: Cell Therapy CMC Readiness for Late-Stage INDs – 5 September 2024.
- In this event, experts from OTP’s Office of Cellular Therapy and Human Tissue CMC will answer questions regarding development and readiness of chemistry, manufacturing, and controls (CMC) data and information for late-stage investigational new drug applications (INDs) – INDs intended to collect primary evidence of effectiveness to support a marketing application for cell therapy and tissue-engineered products.
- Meeting 1: Patient and Care Partner Perspectives on Safety Considerations for Approved Gene Therapy Treatments for Rare Diseases – 20 September 2024.
CBER will host a public patient listening meeting and opening a docket to better understand patient and care partner perspectives on safety considerations and long-term follow-up for approved gene therapy treatments for rare diseases.
Published on the 1st of August 2024 in Catapult’s regulatory round-up for July 2024.
OpenEdition vous propose de citer ce billet de la manière suivante :
adelage (5 novembre 2024). FDA OTP Events, Meetings, and Workshops (Catapult’s regulatory round-up – July 2024). ELSIBI. Consulté le 16 mars 2026 à l’adresse https://doi.org/10.58079/12mjp





