Stay updated with breaking news from Securing Authorisation. Get real-time updates on events, politics, business, and more. Visit us for reliable news and exclusive interviews.
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.
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...