Blog
RSS FeedPosted by Michael Wonder on 11 Jul 2019
Reforming the Orphan Drug Act for the 21st century
11 July 2019 - The pharmaceutical market has undergone radical changes, including markedly increased prices for rare-disease drugs. ...
Posted by Michael Wonder on 10 Jul 2019
A Supreme Court ruling may have made it harder to get some info from the FDA
9 July 2019 - Anyone seeking certain information about a medicine from the FDA may have a harder time getting ...
Posted by Michael Wonder on 22 Jan 2019
FDA chief Scott Gottlieb warns 'we have many hard decisions ahead of us' if government shutdown persists
18 January 2019 - "We are in uncharted territory. This is a watershed moment in the life of this agency," he ...
Posted by Michael Wonder on 11 Jan 2018
New guidance: When can the FDA refuse to file NDAs and BLAs?
10 January 2018 - According to US FDA regulations, the regulatory agency may refuse to file a new drug application ...
Posted by Michael Wonder on 26 Sep 2017
How patient preferences contribute to regulatory decisions for medical devices
25 September 2017 - Since we launched our Patient Preference Initiative as part of our medical device regulatory decision-making process ...
Posted by Michael Wonder on 07 Sep 2017
FDA’s plan to engage the public in the agency’s new effort to strengthen and modernise FDA’s regulatory framework
7 September 2017 - We’re at a moment of extraordinary opportunity to improve the public health. New innovations are giving us ...
Posted by Michael Wonder on 24 Aug 2017
Multidimensional evidence generation and FDA regulatory decision making
22 August 2017 - Evidence linking interventions with health outcomes is the basis for good health care decision making. ...
Posted by Michael Wonder on 02 Aug 2017
Evidence for health decision making — beyond randomised, controlled trials
2 August 2017 - A core principle of good public health practice is to base all policy decisions on the highest-quality ...
Posted by Michael Wonder on 13 Jul 2017
Multidimensional evidence generation and FDA regulatory decision making defining and using “real-world” data
13 July 2017 - Evidence linking interventions with health outcomes is the basis for good health care decision making. ...
Posted by Michael Wonder on 15 Mar 2017
Can a statistical method speed drug approvals?
13 March 2017 - Not likely, says F. Perry Wilson, MD. ...
Posted by Michael Wonder on 13 Dec 2016
Approving a problematic muscular dystrophy drug: implications for FDA policy
13 December 2016 - In September 2016, the US FDA approved eteplirsen (Exondys 51), a new drug for Duchenne muscular ...
Posted by Michael Wonder on 16 Nov 2016
Drug makers to FDA: Let us share off-label study data with payers
16 November 2016 - Now that pharma has prevailed in free-speech legal battles concerning off-label marketing, it’s pushing the FDA ...
Posted by Michael Wonder on 16 Oct 2016
Bad medicine
15 October 2016 - Approving an unproven drug sets a worrying precedent. ...
Posted by Michael Wonder on 18 Jul 2016
Generic drug approvals since the 1984 Hatch-Waxman Act
18 July 2016 - This study uses US FDA data to identify approved generic drugs manufactured between September 30, 1984, and ...
Posted by Michael Wonder on 24 Feb 2016
FDA statement on Senate confirmation of Dr. Robert M. Califf
24 February 2016 - Today the U.S. Senate voted in support of the confirmation of Dr. Robert Califf, M.D. to ...