Public Citizen petitions FDA to withdraw hydroxyethyl starch solutions from the market due to their risks and the availability of safer alternatives.
Hogan Lovells attorneys see the potential for renewed FDA interest in potential data bias based on clinical investigators financial interests.
Attorney James Beck makes the case that if a product contains an FDA-approved Boxed Warning, its risks have been sufficiently emphasized.
Morrison & Foerster attorneys say the 10th Circuit Court of Appeals has held that FDA rejection of a citizen petition can provide clear evidence that ...
FDA assistant commissioner Leslie Ball says a recent training workshop in Mumbai, India, helped local researchers learn more about clinical trial safe...
The FDA Oncologic Drugs Advisory Committee says Pfizers Mylotarg, voluntarily withdrawn in 2010, has a favorable risk/benefit profile in combination w...
Federal Register notice: FDA withdraws approval of two new animal drug applications at the sponsors request because these products are no longer manuf...
FDA sends a second complete response letter to Ocular Therapeutix on an NDA for Dextenza (dexamethasone insert) 0.4mg for treating ocular pain followi...