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Drug Pricing: FDA Considerations Under Recent Executive Orders and Congressional Bills

President Trump’s executive orders and legislative proposals from Congress leverage FDA to help lower drug prices, address anti-competitive practices, and accelerate generic drug approvals....more

FDA Issues Draft Guidance on Biosimilar Interchangeability

Agency outlines flexible, case-by-case approach to demonstrating interchangeability to reference products; emphasizes role of “switching studies” - On January 18, 2017, the US Food and Drug Administration (FDA or...more

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