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Date Update Type Topic 02/08/2022

FDA Roundup: February 8, 2022

The FDA issued a guidance for industry and investigators to announce a policy
discouraging sponsors from developing or seeking approval or authorization for
the use of sanitation tunnels, that spray humans with a mist of disinfectant or
aerosolized antiseptic with the aim of preventing or treating COVID-19. The
agency also warned health care providers, parents and caregivers of pediatric
patients (children) who receive enteral feeding that there is a risk of
strangulation from the use of enteral feeding delivery sets.

Press Release / Public Statement Drugs
Medical Devices 02/04/2022

FDA Roundup: February 4, 2022

The FDA determined that beginning on Feb. 7, the agency will resume conducting
domestic surveillance inspections across all commodities given the decline in
COVID-19 cases across the country. The FDA also issued a draft guidance advising
sponsors on the premarketing assessment of a drug’s effect on blood pressure.
Additionally, the FDA announced its 2022-2025 strategic priorities for the
Center for Devices and Radiological Health, a proposed rule to improve the
security of the drug supply chain as well as a new website showcasing the Center
for Veterinary Medicine’s innovative research to protect human and animal
health.

Press Release / Public Statement Drugs
Animal & Veterinary
Medical Devices 02/01/2022

Coronavirus (COVID-19) Update: FDA Advisory Committee Meeting to Discuss Request
for Authorization of Pfizer-BioNTech COVID-19 Vaccine for Children 6 Months
Through 4 Years of Age

FDA announced a virtual meeting of its Vaccines and Related Biological Products
Advisory Committee on Feb. 15 to discuss the request for emergency use
authorization of the Pfizer-BioNTech COVID-19 Vaccine for use in children 6
months through 4 years of age.

Press Release / Public Statement Biologics

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DRUG DEVELOPERS

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for review, see COVID-19 Therapeutics: General Information for Interested
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   CONTENT CURRENT AS OF:
   
   02/08/2022


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