The head of the U.S. Food and Drug Administration said she will visit India to talk with generic- drug makers and regulators about quality concerns and plans to expand overseas inspections to address the country’s growing role in producing medicines sold in the U.S.
Hospital pharmacists are backing a call by the Food and Drug Administration for added regulation of compounding companies after a meningitis outbreak, calling it a “gray area” with serious implications.
New U.S. drug shortages have fallen by more than half this year after President Barack Obama gave regulators the power to head off potential scarcities, the head of the Food and Drug Administration said.
The Food and Drug Administration is weighing whether to let consumers buy medicines for some chronic conditions without a prescription while speeding approvals of drugs for infection, Alzheimer’s disease and rare conditions.
America’s $93 billion pipeline of generic pharmaceuticals often starts in places like Toansa, a village in northern India where a drug-making facility rises up beside mustard fields and manure-flecked ox-cart tracks.
Altria Group Inc. , Reynolds American Inc. and other cigarette sellers in the U.S. must place graphic images such as corpses and diseased lungs on the warning labels of packages and in advertisements to highlight smoking risks.
U.S. regulators revoked approval of Roche AG’s Avastin as a treatment for metastatic breast cancer, a move the drugmaker has said could put as much as 800 million Swiss francs ($873 million) in revenue at risk.