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- HHS and FDA Release Proposed Rule and Draft Guidance on Importation of Drugs Originally Intended for Foreign Markets
HHS and FDA Release Proposed Rule and Draft Guidance on Importation of Drugs Originally Intended for Foreign Markets
December 19, 2019, Covington Alert
On December 18, 2019, the Department of Health and Human Services (HHS) and the Food and Drug Administration (FDA) issued a notice of proposed rulemaking on “Importation of Prescription Drugs” (the “NPRM”) and a Draft Guidance titled “Importation of Certain FDA-Approved Human Prescription Drugs, Including Biological Products, under Section 801(d)(1)(B) of the Federal Food, Drug, and Cosmetic Act” (the “Draft Guidance”).
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 ...
October 28, 2020, Covington Alert
The outcome of the national elections next week will have consequential implications at the U.S. Food and Drug Administration (FDA). The election may affect the composition of FDA’s leadership team, and stakeholders can expect differences in policies and priorities between a second Trump Administration and a new Biden Administration. Control of the U.S. Senate ...
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.