FDA Has Hinted at It, You Have All Been Waiting, and Now It Is Here – pH adjusters May Be Put to Bed!

Yes, you heard me right; after years of problems caused by those pesky pH adjusters, there is a way around the regulations (and by the way this avenue has always been available for the Agency to utilize).  In a pre-publication of the Federal Resister (here), the FDA says “an ANDA applicant for a drug product […]

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