FDA 2021 OMUFA Fees

On March 26, 2021, the US Food and Drug Administration (FDA) announced its 2021 fees for OTC monograph drug facilities under the Over-the-Counter Monograph Drug User Fee Program (OMUFA). This fee assessment was authorized by the Coronavirus Aid, Relief, and Economic Security (CARES) Act which added a new provision to the Federal Food, Drug and [...]

2021-05-07T19:21:12+00:00FDA|
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FDA Issues Temporary Guidance for Manufacturing Hand Sanitizers

What You Need to Know: On March 20, 2020 (updated on April 15, 2020), FDA issued a temporary policy for the manufacturing of alcohol-based hand sanitizers during the COVID-19 public health emergency.  This temporary guidance only applies to the manufacture of hand sanitizers that use alcohol (ethanol) or isopropanol as the active ingredient. The following [...]

2020-07-22T19:11:26+00:00FDA|
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