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Generic Drug User Fee Act Nearing Finalization

The draft of the Generic Drug User Fee Act (GDUFA) entered its last lap in December before going to Congress for approval with a final public airing of FDA’s “goals letter” at its White Oak, Maryland headquarters that produced little public comment. Written comments on the draft “goals letter” are due by January 6, 2012....

Congressional and FDA Hearings Throw Spotlight on Drug Shortage Problems and Potential Solutions

The increasing number of shortages of medically-necessary pharmaceuticals, and of generic injectable drugs in particular, drew the attention of the US Congress and FDA in separate public hearings held in late September....

Lab Data Integrity at Issue in FDA Warning Letters Sent to China and India

Evidence of unreliable laboratory data has prompted the Office of Compliance at FDA’s Center for Drug Evaluation and Research (CDER) to issue warning letters over the past few months to drug manufacturers in China and India....

Generics Industry Outreach Urged at Q8-10 Implementation Workshop in Estonia

The importance of pulling the generics industry more directly into the QbD/ICH Q8-10 implementation process was stressed by key regulatory and industry officials during the concluding session at the ICH Quality Implementation Working Group (IWG) workshop in Tallinn, Estonia in early June. The workshop was sponsored by the associations PDA and ISPE....

IPQ Special Report — May/June 2009

ANALYSIS OF FDA AND EU GMP ENFORCEMENT ACTIVITY shows inadequate investigation of manufacturing and product nonconformances to be the most pressing concern on both sides of the Atlantic. FDA warning letters and injunctions are frequently linking GMP problems with the manufacturing of products that do not have the required new drug approval or do not […]
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