Following the Money: House And Senate Appropriations Release Draft Bills & Reports Funding FDA For FY 2015

The House and Senate Appropriations Committees with oversight of FDA have been very busy. Both voted out draft bills for FY 2015 that include appropriations for FDA and released draft reports.  Roger Szemraj and the rest of our government relations… Read More
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And They’re Off! FDA Wastes No Time in Implementing its New Compounding Authority

It appears that FDA, like many of us, anticipated the passage of the Drug Quality and Security Act (DQSA) (H.R. 3204).  We previously blogged about Title II of the DQSA here, which focused on drug supply chain security.  Title I, the Compounding Qu… Read More
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Achievement Unlocked! Senate Passes Drug Quality and Security Act for a Safer, More Secure Pharmaceutical Supply Chain

In a time when internecine conflicts within the Congress and between the legislative and executive branch stymie so much important work, the easy passage of the bipartisan Drug Quality and Security Act (DQSA) (H.R. 3204) is cause for celebration.  H… Read More
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Compounding, Again

The election is over, cabinet re-shuffling has begun, and hopefully you properly prepared and stored your food and avoided poisoning family and friends over the Thanksgiving holiday.  As you can imagine, food preparation at a food and drug law firm… Read More
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Can FDA Regulate Compounding? FDA Doesn’t Think So. . . But It Kind of Tried To

As the impact of the deadly meningitis outbreak grows, questions about FDA’s authority to regulate pharmacy compounding have arisen. New England Compounding Center Inc.’s (NECC) tainted, injectable steroid, methylprednisolone acetate, is now link… Read More
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Deadly Meningitis Outbreak Linked To Compounded Steroid— The Tipping Point For Compounders?

Five people are dead and another 35 are very ill due to a fungal meningitis outbreak in six states.  The Centers for Disease Control and Prevention (CDC) and U.S. Food and Drug Administration (FDA) have traced the outbreak to the New England Comp… Read More
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