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- New FDA Guidance Describing Exemptions, Exclusions, and Discretion Relating to Drug Supply Chain Security Act Requirements During the COVID-19 Public Health Emergency
New FDA Guidance Describing Exemptions, Exclusions, and Discretion Relating to Drug Supply Chain Security Act Requirements During the COVID-19 Public Health Emergency
May 5, 2020, Covington Alert
The United States Food and Drug Administration (FDA) recently published a Guidance for Industry, Exemption and Exclusion from Certain Requirements of the Drug Supply Chain Security Act During the COVID-19 Public Health Emergency (Guidance), to (1) clarify the applicability of the Drug Supply Chain Security Act (DSCSA) to certain distribution activities, and (2) set forth an enforcement discretion policy with respect to certain authorized trading partner requirements. The Guidance outlines FDA’s policy on these topics for the duration of the Coronavirus Disease 2019 (COVID-19) public health emergency.
November 9, 2020, Covington Alert
Now that former Vice President Biden has been projected to win the 2020 U.S. Presidential Election, expect the transition to commence from the Trump Administration to a Biden Administration. Control of the U.S. Senate remains in the balance with two runoff elections in Georgia on January 5, but either way, the Senate majority will be razor thin and hence less ...
September 30, 2020, Covington Alert
On September 24, 2020, the Department of Health and Human Services (“HHS”) and the Food and Drug Administration (“FDA”) took major steps toward facilitating the importation of prescription drugs by entities other than the manufacturer, with the stated goal of lowering costs for American consumers.
Former FDA Official Joins Covington
April 1, 2019
WASHINGTON—Julie Dohm has joined Covington's Food, Drug, and Device practice in Washington. Dr. Dohm focuses on regulatory matters for pharmaceutical and biotechnology clients. She has handled cases on a wide range of regulatory topics such as preemption, drug promotion, drug shortage, import-export, exclusivity, and generic drug approval standards. Prior to ...