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Woodcock, AAM Testify on REMS Programs Delaying Generic Competition Access to drugs can be denied through REMS, contracts or self-imposed restrictions. Read More
GAO to Investigate the FDA’s Approval Process for Orphan Drugs The lawmakers requested a comprehensive list of orphan drugs approved since 1983. Read More
Woodcock: FDA Must Hire Specialists to Implement PDUFA VI, 21st Century Cures CDER will require additional big data analysts and social scientists. Read More
Gottlieb Meets with Senate Health Committee Chairman Ahead of Confirmation Hearings Scott Gottlieb has met with the chair of the Senate committee presiding over his confirmation as the next FDA commissioner, Sen. Lamar Alexander (R-Tenn.). Read More
Automation of Process Control within the Pharmaceutical Industry While most pharmaceutical businesses have adopted process automation in one format or another, the technology has evolved considerably over the past few years, leading to improvements in design, efficiency and reliability. One of the major drivers for businesses to increase levels of automation is legislation, but the need to compete in the market place and reduce ... Read More