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Guide to Biosimilars Litigation and Regulation in the U.S., 2022-2023 ed.

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Product details:

Brand: Thomson West
Copyright: 2022
ISBN: 9781731923752
Service #: 42658211
Sub #: 42658210
Pages: 852
Shelf Space: 1 in.
Publication Frequency: Updated as changes in the law dictate
Update format: No updating

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Guide to Biosimilars Litigation and Regulation in the U.S., 2022-2023 ed.

106857147

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Guide to Biosimilars Litigation and Regulation in the U.S. is an understandable guide and go-to reference, providing expert and practical guidance for attorneys working in this burgeoning area of the law.

The title explores each section of the Biologics Price Competition and Innovation Act (BPCIA) as well as an overview of legal and regulatory issues unique to biosimilars that have arisen, or are expected to arise, in litigation concerning biosimilar products.

Related statutes and regulations, litigation summaries, agency guidance, and other relevant materials are included in the extensive appendices.

Features

  • Gives practitioner guidance
  • Highlights areas for consideration during the FDA approval process
  • Highlights areas for consideration during the FDA approval process
  • Gives practitioner guidance