Blog
RSS FeedPosted by Michael Wonder on 01 May 2017
Reform of the Orphan Drug Program - transition arrangements
1 May 2017 - The Orphan Drug Program provides an incentive for sponsors to bring medicines for a small population to ...
Posted by Michael Wonder on 18 Apr 2017
Submissions received and TGA response: orphan drug program
18 April 2017 - The TGA would like to thank respondents who provided submissions in response to the October 2016 ...
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 ...
Posted by Michael Wonder on 26 Dec 2016
Charting a new drug review pathway
25 December 2016 - Why the regulators at the FDA must think surgeons. ...
Posted by Michael Wonder on 19 Dec 2016
G.O.P. plans to replace health care law with ‘universal access’
15 December 2016 - House Republicans, responding to criticism that repealing the Affordable Care Act would leave millions without health ...
Posted by Michael Wonder on 16 Dec 2016
Trump's FDA chief may implement progressive approval for drugs
15 December 2016 - The first potential FDA chief appointee leaked by the Trump transition team is Jim O’Neill. ...
Posted by Michael Wonder on 02 Dec 2016
The four legs of a new health care system
30 November 2016 - The great recession enabled ObamaCare. Now the law’s failure makes reform possible. ...
Posted by Michael Wonder on 01 Dec 2016
Simpler website navigation for regulatory information on human medicines
1 December 2016 - New navigation to help users find information more easily ...
Posted by Michael Wonder on 28 Nov 2016
Could the FDA be dismantled under Trump?
22 November 2016 - Has President-elect Donald Trump put a bull’s-eye on the FDA? ...
Posted by Michael Wonder on 15 Nov 2016
Revising the guideline on first-in-human clinical trials
15 November 2016 - Changes are open for comments until end of February 2017. ...
Posted by Michael Wonder on 15 Nov 2016
Trump just dropped a big hint to the pharmaceutical industry
14 November 2016 - A single sentence in President-elect Donald Trump's health-care platform sends a strong hint to the drug ...
Posted by Michael Wonder on 13 Nov 2016
Donald Trump says he may keep parts of Obama Health Care Act
11 November 2016 - Just days after a national campaign in which he vowed repeatedly to repeal President Obama’s signature ...
Posted by Michael Wonder on 03 Nov 2016
Health reform and the changing safety net in the United States
2 November 2016 - The authors describe the implications of the Affordable Care Act for safety-net health systems and how hospital-based ...
Posted by Michael Wonder on 11 Oct 2016
TGA boss warns about streamlining approvals
3 October 2016 - The head of the Therapeutic Goods Administration, John Skerritt, has warned that federal government reforms to ...
Posted by Michael Wonder on 10 Oct 2016
EU options for improving access to medicines
10 October 2016 - On October 12, the European Parliament’s Environment, Public Health and Food Safety committee will consider the ...