• The US Food and Drug Administration (FDA) has two categories of research that pharmaceutical companies may commit to after a drug or biologic substance is released to the market. A postmarketing requirement (PMR) is required by law or regulation, while a postmarketing commitment (PMC) is one that a drug company agrees to do even though it is not a legal requirement. These studies are frequently found to be either behind schedule or terminated by the company marketing the drug or biologic in a manner that does not conform with the law, regulation, or original commitment. In 2014 only 67% of such studies from Fiscal Year 2008 were either fulfilled or released by the FDA as being no longer necessary. This means that about a third of all post-marketing studies associated with drugs or biologics initiated that year had a nonconforming status.

     

    Companies with drug or biologic products in the market, but subject to a PMR or PMC, are required to submit an annual report on the ongoing study on their product within 60 days of the anniversary of the product’s release. In Fiscal Years 2013 and 2014, about a fifth of these reports were late. In 2013, over 10% of the reports were not received at all, and in 2014 over 20% of the reports were not received. About 75% of total studies were actually on schedule but the lack of reporting on the others makes it difficult to assess the degree of compliance.

     

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    This entry was posted on Monday, October 31st, 2016 By admin

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