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FDA Announces New Fees for Manufacturers of Over-the-Counter Drugs

As we explained in a previous alert, one of the lesser-known provisions of the March 2020 Coronavirus Aid, Relief, and Economic Security (CARES) Act was a significant overhaul of the way that most OTC drugs are regulated in...more

Congress Enacts Sweeping Reforms to Over-the-Counter Drug Regulation as Part of COVID-19 Response Bill

For years, regulators, industry, and lawmakers alike have sought to modernize the regulatory framework under which most over-the-counter (OTC) drugs are marketed in the US. With the enactment of the Coronavirus Aid, Relief,...more

FDA, TTB Announce Emergency Policies to Increase the Domestic Supply of Hand Sanitizer

The coronavirus (COVID-19) outbreak has led to a dramatic increase in the demand for, and a shortage of, hand sanitizer in the US. In response, the US Food and Drug Administration (FDA) and the US Treasury Department’s...more

FDA Temporarily Relaxes Requirements For Alcohol Used in Hand Sanitizers

As we reported earlier this week, in an effort to increase the domestic supply of hand sanitizer, the US Food and Drug Administration (FDA) recently announced policies that temporarily relax certain requirements for the...more

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