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A pair of lawmakers has launched a congressional investigation into dramatic price increases on some generic drugs, but GPhA dismisses the scrutiny as being so narrowly focused that it misses the overall savings from the industry as a whole. Read More
The Indian government is mulling a proposal from a research institute to launch an online registry of foreign and domestic drugs that would improve transparency and knowledge of distributed drugs. Read More
Branded drugmakers have expressed guarded optimism at the announcement of high-level intellectual property talks between the U.S. and India, hoping the discussions will resolve long-standing worries over a lack of effective patent protection by the Indian government. Read More
The UK’s healthcare cost watchdog has recommended against covering Roche’s leukemia drug Gazyvaro for chronic lymphocytic leukemia (CLL) patients who are ineligible for fludarabine-based therapy. Read More
Better postmarket surveillance of generic drugs and a greater understanding of the bioequivalence of hard-to-compare products will top the FDA’s regulatory science priorities under GDUFA in the new fiscal year, the agency said. Read More
The Centers for Medicare and Medicaid Services said it will soon improve the functionality of its week-old physician payments website, but so far it’s not taking action on drug industry concerns that such payments lack vital context. Read More
The UK’s Medicines and Healthcare products Regulatory Agency is seeking suggestions on prescription drugs that would be exempt from EU safety authentication requirements and nonprescription drugs that should bear the safety feature. Read More
Manufacturers of moderate-risk devices with a good record of GMP compliance could see less of government inspectors, under proposed amendments to South Korea’s good manufacturing practice regulations. Read More
A Chinese active pharmaceutical ingredient (API) maker was slammed by the FDA for falsifying batch record signoffs and product labeling, the latest international drugmaker to be caught in the agency’s crackdown on poor data integrity. Read More
The FDA is honing in on roughly eight to 10 quality metrics that the agency plans to collect from drugmakers starting in 2015, and expects to publish a guidance that names them by the end of the year. The selection of 10 metrics could present a significant challenge for industry, however, which has called for collecting only four metrics. Read More