Blog
RSS FeedPosted by Michael Wonder on 17 Jun 2020
Regulators discuss accelerated approvals, Project Orbis at DIA
16 June 2020 - Regulators from the US FDA, European Medicines Agency and Health Canada gave their perspectives on different ...
Posted by Michael Wonder on 16 Jun 2020
Advancing structured decision‐making in drug regulation at the FDA and EMA
11 June 2020 - FDA’s recent benefit‐risk framework was developed for improving the clarity and consistency in communicating the reasoning behind ...
Posted by Michael Wonder on 16 Jun 2020
Supreme Court will not hear generic drug price fixing discovery dispute
16 June 2020 - The U.S. Supreme Court on Monday declined to hear generic drug makers’ challenge to a court ...
Posted by Michael Wonder on 15 Jun 2020
FDA permits marketing of first game-based digital therapeutic to improve attention function in children with ADHD
15 June 2020 - Today, the U.S. FDA permitted marketing of the first game-based digital therapeutic device to improve attention function ...
Posted by Michael Wonder on 15 Jun 2020
Global regulators work towards alignment on policy approaches and regulatory flexibility during COVID-19 – update #4
15 June 2020 - The International Coalition of Medicines Regulatory Authorities convened its regular virtual meeting of regulators from around ...
Posted by Michael Wonder on 15 Jun 2020
COVID-19 update: FDA revokes emergency use authorisation for chloroquine and hydroxychloroquine
15 June 2020 - Today, the U.S. FDA revoked the emergency use authorisation that allowed for chloroquine phosphate and hydroxychloroquine sulphate ...
Posted by Michael Wonder on 14 Jun 2020
EMA management board backs rolling review fees, COVID-19 transparency measures
12 June 2020 - After its June meeting on Thursday, the EMA’s management board said it has approved a new ...
Posted by Michael Wonder on 13 Jun 2020
Antimicrobials benefited from expedited FDA programs more than other drugs
12 June 2020 - Amid concerns over the need for more antimicrobials, a new analysis finds these medicines benefited more ...
Posted by Michael Wonder on 11 Jun 2020
Cell and gene therapies: FDA official on COVID-19 impact
10 June 2020 - Speaking at a session on cell and gene therapies at BIO Digital on Monday, a top US ...
Posted by Michael Wonder on 11 Jun 2020
U.S. FDA Commissioner says agency seeks fast review of COVID-19 products
11 June 2020 - The U.S. FDA is seeking to review treatments and tests for COVID-19 “as fast as we can” ...
Posted by Michael Wonder on 11 Jun 2020
Rare disease therapy development and access remain top FDA priorities during COVID-19
11 June 2020 - The FDA’s work on behalf of people with rare diseases is more important than ever as these ...
Posted by Michael Wonder on 10 Jun 2020
Coalition of attorneys general file third lawsuit against generic drug ‘price-fixing’
10 June 2020 - New York Attorney General Letitia James announced on 10 June, that she and a coalition of 51 ...
Posted by Michael Wonder on 08 Jun 2020
EU actions to support availability of medicines during COVID-19 pandemic – update #7
8 June 2020 - The EU Executive Steering Group on Shortages of Medicines Caused by Major Events held a virtual ...
Posted by Michael Wonder on 03 Jun 2020
Antimicrobial approvals are not bottlenecked by FDA
3 June 2020 - Sponsors seeking US FDA approval for anti-microbial drugs accessed expedited clinical testing and review programs at least ...
Posted by Michael Wonder on 03 Jun 2020
How a US-UK trade agreement could affect NHS drug prices
1 June 2020 - The governments of the UK and US are working on the outlines of a trade agreement. ...