How The US FDA Is Checking For Adequate Controls Against DEG/EG Ingredient Substitution
Agency has increased its efforts to protect the US market from the diethylene glycol and ethylene glycol adulteration linked to hundreds of deaths in seven countries with testing, remote records requests, inspections, import alerts and more. Manufacturing quality compliance director Francis Godwin stresses importance of testing every container, while sharing tips for simplifying the task.
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Revised US FDA Guidance Calls For Testing More Excipients For DEG And EG
Substantial revision of 2007 DEG guidance comes after hundreds of deaths in seven countries that were linked to diethylene glycol and ethylene glycol adulteration. All containers and all lots of certain additional excipients must now be tested, and many others should be.
US FDA Balances Urgent Need For Platinum Chemotherapies Against Intas Plant’s Quality Failures
As politicians demand help for cancer-ridden constituents, the agency allows Indian plant that flunked inspection to resume exporting batches of cisplatin and carboplatin to the US, but only after passing independent 45-day batch certification reviews.
Why Generic Drug Manufacturing Is Faltering And Ways To Bolster It
Academic expert provides insight into the economic and quality challenges behind generic drug shortages, and what to do about it.