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- HHS and FDA Release Proposed Rule and Draft Guidance on Importation of Drugs Originally Intended for Foreign Markets
HHS and FDA Release Proposed Rule and Draft Guidance on Importation of Drugs Originally Intended for Foreign Markets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Administration (FDA) issued a notice of proposed rulemaking on “Importation of Prescription Drugs” (the “NPRM”) and a Draft Guidance titled “Importation of Certain FDA-Approved Human Prescription Drugs, Including Biological Products, under Section 801(d)(1)(B) of the Federal Food, Drug, and Cosmetic Act” (the “Draft Guidance”).
Former FDA Drug Regulatory Adviser Joins Covington in DC
April 5, 2019, Law360
Julie Dohm was featured in Law360 regarding her move to Covington. Ms. Dohm, who joined Covington in March from the FDA, says, “I was excited about trying to get into private practice. I really want to work with people that are the pillars of food and drug law, and a number of those folks are at Covington.”
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 ...
November 7, 2017, Covington Alert
On August 18, 2017, President Donald Trump signed into law the FDA Reauthorization Act of 2017 (FDARA). This law, containing nine titles, reauthorizes and amends the user fee programs for prescription drugs, medical devices, generic drugs, and biosimilars.