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FDA Over-The-Counter Monograph User Fee Requirements

Businesses operating in the over-the-counter drug product space should all be familiar with the changes made by Congress to the regulatory system with the final OTC Monograph reform bill, which was included as part of the Coronavirus Aid, Relief, and Economic Security Act ....

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FDA Begins Modernizing its Resources and Implementing Over-The-Counter Monograph User Fee Requirements | Mintz - Health Care Viewpoints

By now, businesses operating in the over-the-counter (OTC) drug product space should all be familiar with the changes made by Congress to the regulatory system with the final OTC. ....

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Distilleries won't face $14K fee for making hand sanitizer during COVID-19 pandemic

Distilleries won t face $14K fee for making hand sanitizer during COVID-19 pandemic
Distilleries won’t face $14,000 fee for helping make hand sanitizer during COVID-19 pandemic
At the height of the pandemic, Heritage Distilling Company was one of many local distilleries in Washington making alcohol-based hand sanitizer.
SEATTLE - When it was nearly impossible to find hand sanitizer at the peak of the COVID-19 pandemic, distilleries stepped up to help. So, they were surprised to see a hefty fee the government charged them earlier this week. Now, federal officials said the charge was a mistake and business won’t have to pay. ....

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