News & Analysis as of

Imports Manufacturers Federal Food Drug and Cosmetic Act (FFDCA)

McDermott Will & Emery

Imported Drugs: (Possibly) Coming Soon to a State Near You

In recent years, states have been exploring innovative avenues to address rising healthcare costs and ensure access to affordable medication for their residents. One idea gaining traction involves pursuing authorization from...more

Arnall Golden Gregory LLP

A Guide to FDA’s Final Rule on the Importation of Prescription Drugs from Canada

On September 25, 2020, the U.S. Food and Drug Administration issued a final rule entitled, “Importation of Prescription Drugs,” to implement Section 804(b) through (h) of the Federal Food, Drug, and Cosmetic Act (FD&C Act)....more

Hogan Lovells

FDA postpones foreign inspections amid growing concerns over coronavirus (COVID-19)

Hogan Lovells on

On 10 March 2020, FDA announced that it is postponing most foreign inspections through April 2020.  This action comes as the latest in a series of agency responses to the coronavirus (COVID-19) outbreaks in foreign...more

Mintz - Health Care Viewpoints

FDA 2017 Year in Review: Therapeutic Products, Part 2

Yesterday we started off our year-end series of blog posts with the first part of a review of FDA’s actions for 2017 in the therapeutic products space. Part 1 recapped Commissioner Gottlieb’s initiative to tackle drug...more

Akerman LLP

Medical Devices To Be Taxed: Manufacturers and Importers Be Prepared

Akerman LLP on

Beginning January 1, 2013, manufacturers, producers, and importers of medical devices must report and pay a 2.3% excise tax on the sales price of taxable medical device pursuant to Section 4191 of the Internal Revenue Code...more

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