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The FDA needs to provide new incentives for the drug industry to speed the development of pharmaceuticals to treat infectious diseases in developing countries, say Duke University researchers.
The Agency for Healthcare Research and Quality (AHRQ) is rejecting the biotechnology industry’s call for limits in how AHRQ applies its comparative effectiveness data, arguing the suggestions are outside the scope of the agency’s mandate.
The FDA's Center for Devices and Radiological Health (CDRH) issued guidance Feb. 9 it hopes will speed the progress in pharmacogenomics by moving genetic diagnostic tests to the clinical laboratory more quickly, thereby shortening development and review timelines.
Drug companies should supplement their pediatric clinical trials with juvenile animal studies to better determine a drug’s effect on children, according to a new FDA guidance that notes such studies may influence post-marketing, labeling, and use-restriction decisions.
The FDA recommends that drug companies supplement their pediatric clinical trials with juvenile animal studies to better determine a drug’s effect on children, according to a new guidance that notes such studies may influence post-marketing, labeling and use restriction decisions.