Tag Archives: Capitol Hill

Gov't Shutdown Halts FDA Product Submissions and Other Functions

Planning to submit to the FDA today? Think again. The agency put a forced pause on key services and functions – and furloughed 6,620 FDA employees – as a result of last night’s government shutdown. Stephen King, a member of CDER’s communications team at FDA, said in an email that “no new regulatory submissions that […]
Posted in Biotech, compliance, FDA, healthcare, Legal, People, Regulatory, Safety, Strategy | Also tagged , , , , , , , | 1 Comment

Congress Clarifies Drug Compounding, Tracking Policies

Public outrage over deaths from contaminated injectables produced by large compounding pharmacies, along with rising concerns about counterfeit and unauthorized drugs entering the U.S. market, managed to lift the stalemate on Capitol Hill long enough to generate agreement on reform legislation. After months of public hearings and negotiations, Democrat and Republican leaders of the House […]
Posted in FDA, Legal, Manufacturing, Regulatory, Safety, Strategy, Supply Chain, Technology | Also tagged , , , , , , , , , , , , | Leave a comment

Sequestration: How Big a Hit for FDA, Research and Pharma?

The greatly feared federal budget sequestration mandate went into effect March 1, and, initially, the impact was fairly muted. The stock market soared, employment rose and government workers continued on their jobs. Federal agencies, including the Food and Drug Administration (FDA), launched initiatives to comply with the mandated 5% across-the-board cut in spending (in reality […]
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Paul Ryan and Pharma: The Inside Story

by Tom Norton Well, we certainly have a presidential campaign now, don’t we? Good grief. Since Rep. Paul Ryan was named the Republican VP candidate last week, all hell has broken loose!  Given the intensity of the last few days, you’d think the election was tomorrow… And at some point, you do have to ask […]
Posted in FDA, Guest Blog, healthcare, Op-Ed | Also tagged , , , , | 3 Comments
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