Blog
RSS FeedPosted by Michael Wonder on 19 Aug 2020
Inquiry into approval processes for new drugs and novel medical technologies in Australia
19 August 2020 - Following a referral on 13 August 2020 from the Minister for Health, The Hon Greg Hunt ...
Posted by Michael Wonder on 18 Aug 2020
FDA finalises penalties for clinical trial sponsors that don’t share data, but critics say they fall short
18 August 2020 - After a year of deliberation, the FDA released final guidelines for penalising clinical trial sponsors that ...
Posted by Michael Wonder on 18 Aug 2020
The FDA response to COVID-19 at six months: regulatory innovation in the face of a pandemic
18 August 2020 - The COVID-19 pandemic has significantly impacted American society, with more than 160,000 deaths and 5 million cases ...
Posted by Michael Wonder on 16 Aug 2020
Submissions received: scope of regulated software based medical devices
14 August 2020 - A total of 48 submissions were received in response to the Scope of Regulated Software based products ...
Posted by Michael Wonder on 13 Aug 2020
The COVID-19 pandemic could be the last straw for high drug costs
12 August 2020 - New polling shows voters are ready for aggressive actions on prescription drug prices. ...
Posted by Michael Wonder on 12 Aug 2020
CMS proposes changes to Medicaid best price rule: a potential boost to value-based contracting
9 August 2020 - For well over a decade policymakers have declared the healthcare system is moving towards value-based pricing ...
Posted by Michael Wonder on 11 Aug 2020
FDA head pledges 'we will not cut corners' on coronavirus vaccine
10 August 2020 - The head of the FDA pledged Monday that the U.S. "will not cut corners" in its ...
Posted by Michael Wonder on 10 Aug 2020
Return some excess drug revenues to employers, CLHIA says in submission to PMPRB
10 August 2020 - In its submission to the Patented Medicine Prices Review Board’s draft guidelines, the Canadian Life and ...
Posted by Michael Wonder on 10 Aug 2020
Communication@EMA
10 August 2020 - The European Medicines Agency has launched its third communication perception survey. ...
Posted by Michael Wonder on 10 Aug 2020
Stephen Hahn MD, FDA chief, is caught between scientists and the President
10 August 2020 - Many medical experts - including members of his own staff - worry about whether Dr Hahn ...
Posted by Michael Wonder on 05 Aug 2020
State attorneys general: use federal law to lower cost, increase supply of COVID-19 drug remdesivir
4 August 2020 - A bipartisan coalition of attorneys general asked the U.S. Department of Health and Human Services on ...
Posted by Michael Wonder on 04 Aug 2020
Innovative Medicines Canada responds to the revised draft PMPRB Guidelines consultation
4 August 2020 - The Patented Medicine Prices Review Board's revised Guidelines will result in patients losing access to innovative ...
Posted by Michael Wonder on 03 Aug 2020
HHS Secretary Azar statement on court victory for President Trump’s drug pricing agenda
31 July 2020 - On Friday, the U.S. Court of Appeals for the D.C. Circuit ruled that the Trump Administration ...
Posted by Michael Wonder on 31 Jul 2020
Global regulatory workshop on COVID-19 therapeutics #2: agreement on acceptable outcomes for clinical trials
31 July 2020 - International regulators have published a report today on the acceptability of various primary outcomes in the ...
Posted by Michael Wonder on 30 Jul 2020
Pathological complete response in neo-adjuvant treatment of high-risk early-stage breast cancer: use as an endpoint to support accelerated approval
29 July 2020 - This guidance is intended to assist sponsors in designing trials to support marketing approval of medicines and ...