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On Wednesday, April 14, 2021, the US Food and Drug
Administration (FDA) published a long-awaited final guidance document explaining its policy
for conducting remote evaluations during COVID-19.
According to the guidance, FDA will request and conduct voluntary
remote evaluations at (1) facilities where drugs and biologics are
manufactured, processed, packed, or held; (2) facilities covered
under the bioresearch monitoring (BIMO) program; and (3)
outsourcing facilities registered under section 503B of the Federal
Food, Drug, and Cosmetic Act (FDCA). The evaluations do not replace
in-person inspections, and FDA Form 483s will not be issued as a
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On Wednesday, April 14, 2021, the US Food and Drug Administration (FDA) published a long-awaited final guidance document explaining its policy for conducting remote “evaluations” during COVID-19. According to the guidance, FDA will request and conduct voluntary remote evaluations at (1) facilities where drugs and biologics are manufactured, processed, packed, or held; (2) facilities covered under the bioresearch monitoring (BIMO) program; and (3) outsourcing facilities registered under section 503B of the Federal Food, Drug, and Cosmetic Act (FDCA). The evaluations do not replace in-person inspections, and FDA Form 483s will not be issued as a result of the inspection, but the results could be used to support regulatory actions, such as approving a pending product application.
Thursday, April 15, 2021
On Wednesday, April 14, 2021, the US Food and Drug Administration (FDA) published a long-awaited final guidance document explaining its policy for conducting remote “evaluations” during COVID-19. According to the guidance, FDA will request and conduct voluntary remote evaluations at (1) facilities where drugs and biologics are manufactured, processed, packed, or held; (2) facilities covered under the bioresearch monitoring (BIMO) program; and (3) outsourcing facilities registered under section 503B of the Federal Food, Drug, and Cosmetic Act (FDCA). The evaluations do not replace in-person inspections, and FDA Form 483s will not be issued as a result of the inspection, but the results could be used to support regulatory actions, such as approving a pending product application.
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