Attorney Curtis Dombeck says a recent Federal Circuit Appeals Court decision has revolutionized determination of the country of origin for drugs to be...
Federal Register notice: FDA seeks comments on an information collection extension for FDA Rapid Response Surveys.
Pharmacy professor C. Michael White says FDA should eliminate advantages currently enjoyed by clinical trial sites in developing countries.
Merck says that its Phase 3 KEYNOTE-355 trial investigating Keytruda (pembrolizumab), an anti-PD-1 therapy, in combination with chemotherapy met one o...
Equity Bulls says FDA had two observations following its inspection at the Lupin Pithampur Unit 1 facility in India.
FDA clears a Baxter International 510(k) for the Q-NRG+, a metabolic monitoring device that uses indirect calorimetry technology to accurately measure...
FDA releases the FDA-483 with two observations from an inspection at SCA Pharmaceuticals.
Federal Register notice: FDA announces a 3/30 public meeting entitled Patient-Focused Drug Development for Vitiligo.