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Other Therapeutic Proteins Targeting Viral Pathogens Guidance for Industry DRAFT GUIDANCE This guidance document is being distributed for...

Submit Comments by 09/05/2022 Submit Comments Online Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure...

This guidance for industry provides the Agency’s current thinking on how to evaluate out-of- specification (OOS) test results. For purposes of...

ABOUT THIS WEBINAR Please join us as FDA will: Discuss enhanced drug distribution security requirements that go into effect in 2023 under the...

The U.S. Food and Drug Administration (FDA) continued to take action in the ongoing response to the COVID-19 pandemic: As part of the FDA’s...

Today, the U.S. Food and Drug Administration issued a new report titled, “Resiliency Roadmap for FDA Inspectional Oversight,” outlining the...

Summary Company Announcement Hospira, Inc., a Pfizer company, is voluntarily recalling lot DN9185 of Sterile Water for Injection, USP, 100 mL...

During this worldwide public health emergency, the FDA has used a variety of tools to oversee facilities that manufacture FDA-regulated...

The U.S. Food and Drug Administration today announced the following actions taken in its ongoing response effort to the COVID-19 pandemic: The...

The U.S. Food and Drug Administration today announced the following actions taken in its ongoing response effort to the COVID-19 pandemic: The...