AGG Food & Drug Newsletter - June 2021

Arnall Golden Gregory LLP's Food & Drug Newsletter is a monthly update of legal and regulatory issues that affect the FDA-regulated community and highlights articles from members of our Food & Drug practice, as well as from colleagues in other related life science disciplines.

Industry Insights

Fast Times at FDA: Explaining Accelerated Approval to Ridgemont High’s Jeff Spicoli
By: Alan G. Minsk & Genevieve M. Razick

TheThe Food and Drug Administration recently approved a drug product to treat Alzheimer’s disease under the accelerated approval pathway, putting the spotlight back on what exactly is “accelerated approval?” This Bulletin will focus on this regulatory pathway and how drug companies might use it to their benefit. So, in a nod to the 1982 classic movie, “Fast Times at Ridgemont High,” we will try to explain the concept of accelerated approval plain and simple, as though we were talking to Jeff Spicoli, the character played by Sean Penn. This Bulletin will not discuss the specific drug approval. More >

Sooner or Later, Everything Old is New Again: FDA Issues Draft Guidance Addressing Remanufacturing of Medical Devices
By: Carolina M. Wirth

The Food and Drug Administration issued new draft guidance titled, “Remanufacturing of Medical Devices,” on June 17, 2021, with the goal of clarifying whether activities performed on medical devices are considered remanufacturing. As noted by William Maisel, M.D., Director of the Office of Product Evaluation and Quality in FDA’s Center for Devices and Radiological Health, “[i]t is important for industry personnel, such as original equipment manufacturers, servicers and remanufacturers, to have a clear understanding of activities that are considered remanufacturing so that they can apply appropriate statutory and regulatory requirements which exist to keep the American public safe.” More >

Let the (Re)contracting Begin: European Commission Adopts New Standard Contractual Clauses for International Data Transfers
By: Kevin L. Coy, Montserrat M. Miller, & Erin E. Doyle

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

DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

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