CBER will host a public patient listening meeting to better understand patient and carer perspectives on enrollment of rare disease patients into gene therapy clinical trials in the pre-symptomatic or early symptomatic stages of their...
This draft guidance provides recommendations to applicants of human prescription drug and biological products on appropriate placement and content of drug interaction (DI) information in labeling as described in the regulations for the content and format of...
The FDA’s CBER OTP is hosting its next virtual town hall on 12th December 2024. Experts from OTP’s Office of Review Management & Regulatory Review (ORMRR) will answer questions regarding best practices for interacting with OTP....
This chapter covers the clinical applications, manufacturing processes and analytical methods of gene therapy products, which are constantly evolving. The current amendment proposals include, for example, the following points: Delete the reference to “Safety Tests-Biologicals”...
In response to the recent approval of many new gene therapy medicinal products (GTMPs), the European Pharmacopoeia Commission (EPC) has defined a new approach to these innovative medicinal products. This webinar will provide guidance on...
3. Clinical Trial Safety Monitoring and Reporting for Investigational Products (Medicines and Medical Devices) End Date: 27 October 2024 Stakeholder Consultation Text published on the 1st of October 2024 in Catapult’s Regulatory Round-up – September 2024...
2. Considerations for First-In-Human (FIH) and Early Phase Clinical Trials End Date: 27 October 2024 Stakeholder Consultation Text published on the 1st of October 2024 in Catapult’s Regulatory Round-up – September 2024 (catapult.org.uk).
1. Guideline on the Regulation of Therapeutic Products in New Zealand End Date: 27 October 2024 Stakeholder Consultation Published on the 1st of October 2024 in Catapult’s Regulatory Round-up – September 2024 (catapult.org.uk).
Title Consultation Period Category 2. The Accreditation Scheme for Conformity Assessment (ASCA) Program Draft Guidance for Industry, Accreditation Bodies, Testing Laboratories, and Food and Drug Administration Staff End date: 23rd December 2024 Guidance Posted...
On 14th November 2024, the FDA’s Center for Biologics Evaluation and Research (CBER) Office of Therapeutic Products (OTP) is hosting a virtual scientific public workshop on the clinical use of integration site analysis (ISA) during long...
