A partial United States (US) Government shutdown has hindered the Food and Drug Administration’s (FDA’s) ability to accept and review regulatory submissions. A notice from the FDA on Government funding lapses, which started in December 2018, states that currently the FDA has no legal authority to collect user fees assessed for their 2019 fiscal year, which prevents the FDA from accepting new regulatory submissions such as 510(k)s and Premarket Applications (PMA) that require fees until Congress and the White House restore full funding. If you are planning to submit applications for US market authorisation in early 2019, you should factor these operational delays at FDA into your commercialisation plans. Read more “Partial US Government shutdown is straining the FDA”
Year: 2019
MHRA releases response to consultation on EU exit no-deal legislative proposals
With the United Kingdom (UK) leaving the European Union (EU) on 29th March 2019, the Medicines and Healthcare Products Regulatory Agency (MHRA) has released updated guidance which outlines the UK’s proposed arrangements for medicine, medical device and clinical trial regulation if the UK leaves the EU with no deal. Read more “MHRA releases response to consultation on EU exit no-deal legislative proposals”
MHRA releases final consultation response for the Falsified Medicines Directive
A public consultation was launched by the Government in July 2018 regarding actions that need to be taken to ensure that the United Kingdom (UK) meets its obligations to apply the provisions of the Falsified Medicines Directive (FMD). The FMD requires ‘safety features’ to be applied to the packaging of specified medicinal products. The consultation closed on 23rd September 2018, and the final consultation response has been published with the Medicines and Healthcare Products Regulatory Agency’s response to over 50 replies that were received from a variety of stakeholders. Read more “MHRA releases final consultation response for the Falsified Medicines Directive”