The Arnall Golden Gregory LLP Food and Drugs Newsletter is a monthly update on legal and regulatory issues affecting the FDA-regulated community and highlights articles from members of our Food and Drugs practice as well as colleagues in other disciplines. related to the science of life.

Industry Overview

FDA Quick Time: Explaining Ridgemont High’s Jeff Spicoli Accelerated Approval
By: Alan G. Minsk & Genevieve M. Razick

The Food and Drug Administration recently approved a drug product to treat Alzheimer’s disease under the accelerated approval pathway, bringing back into focus what exactly is “accelerated adoption?” This Bulletin will focus on this regulatory pathway and how drug companies can use it to their advantage. So in a nap of the classic 1982 movie, “Fast Times at Ridgemont High,” we’re going to try to explain the concept of accelerated adoption simply and simply, as if we were talking to Jeff Spicoli, the character played by Sean Penn. This Bulletin will not discuss specific medication approval. More>

Sooner or later, everything old is new again: FDA issues draft guidelines addressing medical device reconstruction
By: Carolina M. Wirth

The Food and Drug Administration issued a new draft guideline entitled, “Reproduction of Medical Devices”, on June 17, 2021, with the aim of clarifying whether activities performed on medical devices are considered to be produced again. As noted by William Maisel, MD, Director of the Office of Product Evaluation and Quality at the FDA Center for Radiological Equipment and Health, “[i]It is important that industry personnel, such as original equipment manufacturers, service technicians and new manufacturers, have a clear understanding of the activities considered to be reproduction so that they can enforce the appropriate legal and regulatory requirements which exist to keep the American public safe. “More>

Let (re) contracting begin: European Commission adopts new standard contractual clauses for international data transfer
By: Kevin L. Coy, Montserrat M. Miller, & Erin E. Doyle

The European Commission (“EC”) has adopted a new long-awaited series of standard contractual clauses (“SCC”) for the transfer of personal data to third countries outside the European Union (“EU”) and the European Economic Area ( “EEA”) that has not been found by the EU to have “adequate” data protection laws. More>