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PREP Act declaration amended to clarify coverage of certain products not directly used for COVID-19

On Monday, the U.S. Department of Health and Human Services (HHS) issued a second amendment (the Amendment) to the March 10, 2020 Declaration under the Public Readiness and Emergency Preparedness (PREP) Act for Medical...more

HHS Issues Advisory Opinion Encouraging a Broad Reading of its PREP Act Declaration

On April 14, 2020, the Department of Health and Human Services (HHS) General Counsel issued an advisory opinion (“the Opinion”) on the March 10, 2020 Public Readiness and Emergency Preparedness Act (“PREP Act”) Declaration...more

COVID-19 Update: FDA Issues Minor Updates to Guidance on Hand Sanitizer Production

In March, the Food and Drug Administration (FDA) issued guidance documents, first revised on March 27, temporarily relaxing certain regulatory requirements for the production of alcohol-based hand sanitizers, to respond to...more

COVID-19: Daily Report for Life Sciences and Health Care Companies (UPDATED)

The Daily Report is a compilation of COVID-19 (coronavirus) news briefs from around the world to help life sciences and health care companies stay current in this challenging time. ...more

COVID-19 Update: FDA and TTB Response to Increased Demand for Alcohol-Based Hand Sanitizer Production

As the novel coronavirus crisis continues to escalate, the demand for hygienic products such as hand sanitizer has dramatically increased. In response, many businesses, such as food and industrial and beverage alcohol...more

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