All news articles for September 2012

Health Canada's new risk-based inspection classification

UPDATE

Health Canada launches risk-based inspection classification system

By Natalie Morrison

Since the publication of this article, in-PharmaTechnologist.com has been in touch with Health Canada to find out that the "updates" to the guidance document were actually to the font, not to the regulations. Health Canada launched no disclaimer...

FDA reviews cancer drugs faster then EMA

US OKs cancer drugs faster than Europe, Tufts

US regulators approve cancer drugs faster than other medications and much faster than their European counterparts according to a new survey by the Tufts Center for the Study of Drug Development. 

FDA warning for DPT Labs

update

FDA criticizes DPT's efforts to fix sterility problems

By Gareth Macdonald

US CDMO DPT Labs has not done enough to investigate sterility failures observed during a March inspection according to the Food and Drug Administration (FDA) which wants a ‘comprehensive evaluation’ of sterile drug operations.

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