FDA 'may require' post-marketing studies to analyse long-term effects of breast cancer drugs

21 June 2021 - The US FDA "may require” or seek agreement from sponsors to conduct post-marketing studies to analyse ...

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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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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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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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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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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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Drugs approved with limited data aren’t always well-tested later

19 May 2017 - New medicines that win U.S. marketing approval without conclusive evidence of their effectiveness aren't always proven ...

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Publication and reporting of the results of post-market studies for drugs required by the US FDA, 009 to 2013

15 May 2017 - Advancing scientific knowledge depends on the timely dissemination of research results, including those from medical product research ...

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