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Life Sciences 2024 - Life Sciences, Biotechnology & Nanotechnology

11. COVID-19 and Life Sciences</strong>, the US government has used a wide variety of public procurement and funding strategies for needed medical countermeasures during the pandemic. ....

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Life Sciences 2021 Guide - Food, Drugs, Healthcare, Life Sciences

1 . LIFE SCIENCES REGULATORY FRAMEWORK
1.1 Legislation and Regulation for Pharmaceuticals and Medical
Devices
The primary legislation governing the authorisation, marketing,
sale and supply of pharmaceutical products by the US Food and Drug
Administration (FDA) is the Federal Food, Drug, and Cosmetic Act
(FD&C Act), which has been amended many times over the years to
reflect increasing FDA mandates for the regulation of
pharmaceutical products. The Public Health Service Act (PHS Act) is
the specific authority utilised to approve or license biologic
(including biosimilar) products. The primary FDA regulations
governing drugs and biologics are found at Chapter 21 of the Code
of Federal Regulations. Controlled substances, such as opioids, are ....

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