7 February 2024 - CDER’s Office of Generic Drugs and the EMA launched a voluntary pilot program to facilitate concurrent discussions ...
1 November 2023 - There has been “continued growth” in the number of applications submitted to Project Orbis, and the ...
28 July 2023 - The FDA and the EMA recently completed the first collaborative assessment of a proposed post-approval change ...
23 February 2023 - Patients with rare diseases are experts in their health condition. They provide a unique perspective, and ...
11 October 2022 - The chairs welcome participants to the first bilateral under the new Work Plan between EUnetHTA 21 ...
7 September 2022 - We compare and contrast the two initiatives to bring new medicines to the market faster. ...
2 September 2022 - The TGA has approved two new medicines as part of the Access New Active-Substance Work-Sharing Initiative. ...
20 July 2022 - EMA has endorsed a joint statement calling for international collaboration to enable the generation and use ...
27 June 2022 - The Biden administration wants to reach a narrow sectoral trade agreement with the Swiss pharmaceutical industry, ...
20 June 2022 - Lessons learned from international collaboration on observational research during the pandemic were highlighted during the latest global ...
17 May 2022 - The US FDA's top biologics regulator said the use of a “playbook” or platform approach ...
12 April 2022 - The EMA and the European Network for Health Technology Assessment (EUnetHTA) 21 consortium have published a joint ...
22 February 2022 - The European Medicines Regulatory Network has adopted a Common Standard for the electronic product information on medicines ...
13 January 2022 - On 12 January, regulators from around the world discussed the global regulatory response to the COVID-19 Omicron ...
14 December 2021 - Vaccines have played a critical role in fighting the COVID-19 pandemic. However, medicines can still play ...