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The FDA Oncologic Drugs Advisory Committee says Pfizers Mylotarg, voluntarily withdrawn in 2010, has a favorable risk/benefit profile in combination w...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...
Andropharm recalls all lots of Sten Z and M1 Alpha capsules because they contain derivatives of anabolic steroids, which makes them unapproved drugs.