Blog
RSS FeedPosted by Michael Wonder on 10 Sep 2019
Why do post-marketing drug studies required by the FDA take so long?
10 September 2019 - Often times when a new drug is approved by the FDA, the agency requires more studies be ...
Posted by Michael Wonder on 13 Jun 2019
Review of Rotarix
12 June 2019 - TLV has decided to initiate a review of the drug Rotarix due to the Government's decision ...
Posted by Michael Wonder on 16 Nov 2018
Statement by FDA Commissioner Scott Gottlieb on the FDA’s efforts to hold industry accountable for fulfilling critical post-marketing studies of the benefits, safety of new drugs
16 November 2018 - The FDA remains committed to ensuring that FDA-approved drugs are safe and effective for Americans. As ...
Posted by Michael Wonder on 17 Aug 2018
Post-market review of the use of biologics in the treatment of severe chronic plaque psoriasis
17 August 2018 - The PBAC minutes pertaining to the draft review report for the post-market review of the use of ...
Posted by Michael Wonder on 05 Jun 2018
Postmarket studies required by the US FDA for new drugs and biologics approved between 2009 and 2012: cross-sectional analysis
24 May 2018 - Between 2009 and 12, the FDA approved 97 new drugs and biologics for 106 indications with at ...
Posted by Michael Wonder on 21 May 2018
Draft report for the post-market review of medicines for pulmonary arterial hypertension
21 May 2018 - The draft report for the post-market review of medicines for pulmonary arterial hypertension is available for public ...
Posted by Michael Wonder on 30 Jan 2018
Post-market review of chronic obstructive pulmonary disease medicines – final report released
30 January 2018 - The final report and outcomes of the post-market review of chronic obstructive pulmonary disease medicines is now ...
Posted by Michael Wonder on 18 Jan 2018
Draft report for the post-market review of the use of biologics in the treatment of severe chronic plaque psoriasis
18 January 2018 - The draft report for the post-market review of the use of biologics in the treatment of severe ...
Posted by Michael Wonder on 20 Dec 2017
Post-market review of ezetimibe - final report
20 December 2017 - The final report for the post-market review of ezetimibe and PBAC recommendations for the post-market review of ...
Posted by Michael Wonder on 11 Dec 2017
Drug makers continue to owe FDA numerous clinical trials
7 December 2017 - Under various circumstances, the FDA may require a drug maker to run a post-marketing study, but ...
Posted by Michael Wonder on 08 Dec 2017
Consumer outcome statement for the post-market review of PAH medicines
8 December 2017 - A consumer session was held with patients with PAH and their carers during the PHAA Members Carers ...
Posted by Michael Wonder on 08 Dec 2017
Post-market review of the use of biologics in the treatment of severe chronic plaque psoriasis - stakeholder forum outcome
8 December 2017 - A stakeholder forum was held for the post-market review of the use of biologics in the ...
Posted by Michael Wonder on 07 Dec 2017
FDA required studies of approved drugs make a big difference for public health
7 December 2017 - Drugs are approved by FDA based upon substantial evidence from clinical trials that the medicine will be ...
Posted by Michael Wonder on 26 Jul 2017
Post-market review of pulmonary arterial hypertension medicines – public consultation process
26 July 2017 - The public consultation process on the post-market review of the pulmonary arterial hypertension medicines has now ...
Posted by Michael Wonder on 25 Jul 2017
PBAC to conduct stakeholder forum on the post-market review of the use of biologics in the treatment of severe chronic plaque psoriasis
25 July 2017 - A stakeholder forum will be held for the post-market review of the use of biologics in the ...