Q1 & Q2 Differences Between RLD and Proposed Generic May Get Help from Legislation

Yesterday, “U.S. Senators Rand Paul (R-KY) and Maggie Hassan (D-NH), both members of the Health, Education, Labor, and Pensions Committee, reintroduced bipartisan legislation to streamline the approval process for generic medications, which are often significantly cheaper than their brand-name counterparts” says a release from Senator Paul’s office (here).  If passed, the bill would direct the […]

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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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