Blog
RSS FeedPosted by Michael Wonder on 22 Feb 2018
Federal right-to-try legislation — threatening the FDA’s public health mission
22 February 2018 - A bill passed by the Senate would sharply curtail the FDA’s oversight of access to investigational drugs. ...
Posted by Michael Wonder on 08 Feb 2018
Rejuvenating regenerative medicine regulation
7 February 2018 - The FDA recently made long-awaited progress toward protecting patients from interventions involving human cell- and tissue-based products ...
Posted by Michael Wonder on 23 Jan 2018
The one year anniversary of the Oncology Center of Excellence
19 January 2018 - One year ago, 19 January 2017, FDA officially launched the Oncology Center of Excellence to leverage the ...
Posted by Michael Wonder on 16 Jan 2018
Statement from FDA Commissioner in response to GAO report regarding FDA’s ongoing commitment to employing a least burdensome approach to device review
16 January 2018 - To encourage innovation and provide patients with access to the latest safe and effective medical technologies, we ...
Posted by Michael Wonder on 11 Jan 2018
Many “firsts” for CDER’s 2017 drug approvals reflect innovation and enhanced patient care
10 January 2018 - In 2017, FDA’s Center for Drug Evaluation and Research approved many new drugs never before marketed in ...
Posted by Michael Wonder on 09 Jan 2018
FY 2017 Report from the Director
8 January 2018 - The Center for Biologics Evaluation and Research worked diligently during Fiscal Year 2017 to fulfil its ...
Posted by Michael Wonder on 07 Dec 2017
FDA seeks to speed approvals of generic drug-device combos
5 December 2017 - New FDA guidance will make it easier for generic companies to get drug-device combination products approved. ...
Posted by Michael Wonder on 18 Nov 2017
U.S. FDA extends review for Tlando; Advisory Committee meeting date of 10 January 2018 remains unchanged
17 November 2017 - Lipocine today announced the U.S. FDA has extended the review period for the new drug application ...
Posted by Michael Wonder on 13 Oct 2017
A ‘holy cow’ moment: the FDA approved a record number of generics
12 October 2017 - As the FDA attempts to foster more competition in the prescription drug market, the agency appears ...
Posted by Michael Wonder on 04 Oct 2017
Expanded access: FDA describes efforts to ease application process
3 October 2017 - FDA has a long history of supporting patient access to investigational new treatments. ...
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 16 Aug 2017
Flimsy evidence behind many FDA approvals
16 August 2017 - Many drugs granted accelerated approval by the U.S. FDA lack clear evidence of safety and effectiveness, ...
Posted by Michael Wonder on 15 Aug 2017
Characteristics of pre-approval and post-approval studies for drugs granted accelerated approval by the US Food and Drug Administration
15 August 2017 - The FDA granted accelerated approval to 22 drugs for 24 indications. ...
Posted by Michael Wonder on 01 Jun 2017
Health policy trials
31 May 2017 - Clinical trials are most commonly associated with drugs and devices, but there are notable examples of trials ...
Posted by Michael Wonder on 13 Feb 2017
Grassley launches inquiry into orphan drugs after KHN investigation
10 February 2017 - Republican Sen. Chuck Grassley, chairman of the Senate Judiciary Committee, has opened an inquiry into potential ...