News Archive

EMA - PRAC 11-14 April 2023

26th April 2023

Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 11-14 April 2023

EMA - Reducing risks to human and animal health from exposure to N-methyl pyrrolidone in veterinary medicines

26th April 2023

On 8 December 2022, EMA’s veterinary medicines committee, the CVMP, recommended new measures to reduce the risks from exposure to the excipient N-methyl pyrrolidone (NMP) for women who may handle NMP-containing veterinary medicines and animals that are given these medicines.

Read More+

EMA - Single-arm trials as pivotal evidence for the authorisation of medicines in the EU

26th April 2023

EMA has opened a public consultation on a PDF icon reflection paper that discusses key concepts for single-arm clinical trials that are submitted as pivotal evidence in support of marketing authorisation applications for medicines in the European Union (EU).

Read More+

FDA - A Risk-Based Approach to Monitoring of Clinical Investigations Questions and Answers

26th April 2023

This guidance provides information on risk-based approaches to monitoring the conduct of clinical investigations of human drug and biological products, medical devices, and combination products.

Read More+

FDA - Final Guidance on Animal Drug User Fees and Fee Waivers and Reductions

26th April 2023

This version of the guidance replaces the version made available in July 2017. This revision of the guidance document updates hyperlinks, mailing, and contact information.

Read More+

FDA - The Office of New Drugs' Efforts to Expand Regulatory Science Research

26th April 2023

CDER’s Office of New Drugs (OND) developed a research program in 2018 to centralise and enhance its regulatory science research activities. Recently, the OND Research Program (OND-RP) published its first two fiscal year annual reports

Read More+