Post-market review of medicines for smoking cessation

24 October 2019 - A public consultation process for the post-market review of medicines for smoking cessation will be open ...

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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 ...

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Review of Rotarix

12 June 2019 - TLV has decided to initiate a review of the drug Rotarix due to the Government's decision ...

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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 ...

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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 ...

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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 ...

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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 ...

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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 ...

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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 ...

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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 ...

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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 ...

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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 ...

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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 ...

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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 ...

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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 ...

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