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FDA BRIEFS

Coronavirus (COVID-19) Update: FDA Gives Flexibility to NYS Department of Health, FDA issues Emergency Use Authorization Diagnostic Testing

Yesterday, the U.S. Food and Drug Administration took two significant actions in the agency's ongoing and aggressive commitment to address the coronavirus outbreak (COVID19).

Coronavirus Disease 2019 (COVID-19) Update: Foreign Inspections

Today, the U.S. Food and Drug Administration (FDA) provided an update on the status of FDA inspections outside of the U.S. in response to the COVID-19 outbreak. After careful consideration, the FDA is postponing most foreign inspections through April, effective immediately. Inspections outside the U.S. deemed mission-critical will still be considered on a case-by-case basis.

FDA Proposes Broad Approach for Conducting Safety Trials for Type 2 Diabetes Medications

The new draft guidance does not contain the recommendation that sponsors of all new therapies for type 2 diabetes uniformly rule out a specific degree of risk for ischemic cardiovascular adverse outcomes, which was recommended in previous guidance and has typically been done through cardiovascular outcome trials.

Coronavirus Update: FDA and FTC Warn Seven Companies Selling Fraudulent Products that Claim to Treat or Prevent COVID-19

These products are unapproved drugs that pose significant risks to patient health and violate federal law.