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....
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).
This virtual training for representatives of patients, consumers and healthcare professionals’ organisations aims at presenting an overview of medicines regulatory activities. Using a combination of presentations, plenary discussions and breakout sessions, participants will learn more...
After years of jostling with industry, failed legislative efforts, and some false starts, the US Food and Drug Administration (FDA) has unveiled its plan to bring laboratory developed tests (LDTs) into its regulatory fold over...
Annual Report of the Human Medicines Regulations 2012 Advisory Bodies – the Commission on Human Medicines and the British Pharmacopoeia Commission. Read the update from Medicines and Healthcare products Regulatory Agency published on 30 July 2024.
The Medicines and Healthcare products Regulatory Agency (MHRA) has today (9 May 2024) launched AI Airlock, its new regulatory sandbox for AI as a Medical Device (AIaMD). Read the press release from Medicines and Healthcare products...
Letters requesting a set of regulators to update their strategic approach to AI, with the intention of increasing the transparency around how they are implementing the AI Regulation White Paper proposals. Read the press release from...
Government seeks views on proposed additions to the Health Protection Notification Regulations 2010. “The Health Protection Notification Regulations 2010 (HPNR) help us respond promptly to suspected cases of infectious disease that could have an impact...
Today the HTA issued regulatory updates about living donation cases. The update comes as reminder about the need for vigilance and robust procedures to manage the ongoing threat of human trafficking for organ removal. Published...
The FDA is establishing a Rare Disease Endpoint Advancement (RDEA) Pilot Program to support novel endpoint efficacy development for drugs that treat rare diseases. The RDEA Pilot Program fulfills a commitment under the Prescription Drug...
