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The Food and Drug Administration (FDA) issued two Emergency Use Authorizations (EUAs) for biological products during the COVID-19 pandemic, one requested by Pfizer, Inc., and the other by ModernaTX, Inc. These Authorizations allow the use of vaccines to help manage the public health emergency declared by the Secretary of Health and Human Services. The Authorizations include specific conditions and are part of efforts to protect public health and national security in response to the SARS-CoV-2 virus, which causes COVID-19. The FDA ensures that such products can be used when there are no adequate, approved alternatives available.

Pfizer, Inc. has submitted a proposal to the Foreign-Trade Zones Board to allow specific production activities at its Kalamazoo, Michigan facilities within Subzone 43E. This proposal covers the production of a pharmaceutical intermediate product called phthalimido lactol, using a foreign-supplied material, 3 phthalimidopropionaldehyde (3-PPA), both with a duty rate of 6.5%. The foreign component may be subject to certain duties based on its country of origin and must be admitted to the zone in a specific status under U.S. trade regulations. Public comments are invited until April 28, 2025, and further details can be found on the Board's website or by contacting Diane Finver.