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By the end of March, the Center for Drug Evaluation and Research (CDER)’s Office of Strategic Programs (OSP) will have met its first Prescription Drug User Fee Act (PDUFA) VII goal: enhancing internal systems review of digital health technology (DHT)-related submissions — enabling the agency to better receive and digest submissions that contain reams of data from, for example, wearable devices. Read More
The European Medicines Agency’s Pharmacovigilance Risk Assessment Committee (PRAC) will review data on medicines containing pseudoephedrine hydrochloride following reports that the decongestant drugs are associated with two potentially serious vasoconstrictive brain conditions. Read More
Indian generics company Sun Pharmaceuticals is facing yet another quality control issue as it recalls several lots of its blood pressure medication diltiazem hydrochloride in the U.S., after samples failed FDA impurity and dissolution testing. Read More
Two bipartisan bills reintroduced in the new Congress by Sens. Amy Klobuchar (D-Minn.) and Chuck Grassley (R-Iowa) that seek to curtail prescription drugs costs have successfully passed the Senate Judiciary Committee, paving the way for their consideration by the full chamber. Read More
The guidance sets out the conditions under which the FDA generally does not intend to take regulatory action regarding stability testing and expiration date requirements. Read More
The agency said the conditions that created the need for the policy described in the document have evolved and the policy is no longer needed. Read More
Newly released federal guidance details how the federal government will punish drug companies that hike prices faster than the rate of inflation for some prescription Medicare medicines — a move some lawmakers view as long overdue. Read More
FDA Commissioner Robert Califf says the agency needs to improve how it makes use of advisory committees, likening them to artificial intelligence (AI) algorithms, which need constant input to function effectively. Read More
The FDA highlighted the need for long-term neurodevelopmental studies by sponsors of neonatal medical products — whether a drug, biologic product or device — in a new draft guidance released Friday. Read More
The FDA has updated its guidance on the compounding of ibuprofen oral suspension products to include state-licensed pharmacies and federal facilities. Read More