Tag Archives: legislation

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

Congress Move Promptly to Finalize FDA User Fees

Legislation fails to establish a national track-and-trace system, but tackles shortages, orphans. House and Senate leaders announced final agreement June 18, 2012 on legislation that authorizes industry user fees to support Food and Drug Administration regulatory programs. The bipartisan measure moved through Congress quickly with an eye to avoid getting tangled up in fallout from […]
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Rare Diseases Lead to Unique Legislation

Since 1983, pharma and patent organizations have been working together to influence policy aimed at improving the lives of those with rare diseases. In 1983—with the help of Abbey Meyers and the drive she had to help her son (more on that here)—the Orphan Drug Act was passed to incentivize pharma to step up and […]
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US Mid-Term Elections: What It Means for Pharma

Daily News Nugget US Mid-Term Elections:  What it Means for Pharma Drink up, even if it’s  only old wine in new bottles… Yesterday’s mid-term congressional poll barely changes the stakes for pharma in its pursuit of its US legislative and regulatory agenda.    The key message coming out of the results is stalemate on the […]
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NICE News or Bad News?

Far from losing its mojo, the UK’s National Institute for Health and Clinical Excellence (NICE) will simply be sharing the stage with a range of new players under NHS reform — none of whom look supportive of the R&D industry. The big issue for industry in the UK this week is handicapping the future of […]
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