Here comes the 21st Century Cures Act

Although it’s being called the “the biggest health reform bill since the Affordable Care Act,” and has been promoted in an unusually aggressive, multi-year effort by Rep. Fred Upton (R-MI), chair of the House Energy and Commerce Committee, the 21st […]

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Pharma pricing and antitrust law

With US sales of close to $300 billion dollars during 2015, the pharmaceutical industry is both a vital part of the national economy and an intensely competitive business. As in any competitive business, price competition, including discounts and rebates, can […]

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5 CAPA best practices for clinical research

In pharmaceutical and biopharmaceutical manufacturing, it is generally assumed that somewhere along the process of manufacturing a product, something is likely to go wrong that could affect quality. When that happens, the quality issue must be resolved in a timely, […]

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