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Agency Alerts

August 26, 2022 Agency Alerts

FDA Announces Availability of Multiple Draft Guidances – Drug Information...

Today, FDA announced the availability of the following draft guidances for industry,…

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August 25, 2022 Agency Alerts

FDA – Tobacco Products: Principles for Designing and Conducting Tobacco...

FDA – Tobacco Products: Principles for Designing and Conducting Tobacco Product Perception…

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August 23, 2022 Agency Alerts

EMA: Monkeypox

The European Medicines Agency (EMA) is supporting the European Union’s (EU) response…

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August 22, 2022 Agency Alerts

FDA Issues Revised Draft Guidance on Charging for Investigational Drugs...

August 2022 Draft Guidance This guidance provides information for industry, researchers, physicians,…

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August 17, 2022 Agency Alerts

Hydrogen Peroxide-Based Contact Lens Care Products: Consumer Labeling Recommendations –...

Draft Guidance for Industry and Food and Drug Administration Staff AUGUST 2022…

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August 16, 2022 Agency Alerts

Replacement Reagent and Instrument Family Policy for In Vitro Diagnostic...

GUIDANCE DOCUMENT – Guidance for Industry and FDA Staff AUGUST 2022 In…

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August 16, 2022 Agency Alerts

FDA Issues Over-the-Counter Hearing Aids Final Rule and Guidance on...

Today, the U.S. Food and Drug Administration (FDA) issued a final rule:…

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August 15, 2022 Agency Alerts

FDA Regional Implementation Guide for E2B(R3) Electronic Transmission of Individual...

This technical specifications document is to assist interested parties in electronically submitting…

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