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. 

In This Issue

• Fast Times at FDA: Explaining Accelerated Approval to Ridgemont High’s Jeff Spicoli
• Sooner or Later, Everything Old is New Again: FDA Issues Draft Guidance Addressing Remanufacturing of Medical Devices
• Let the (Re)contracting Begin: European Commission Adopts New Standard Contractual Clauses for International Data Transfers
• AGG Food & Drug Podcast Episode 7: Fee Waivers for Small Businesses: Who Qualifies for the Small Business User Fee Waiver for Drugs and Biologics and How to Apply from an FDA and Corporate Perspective
• Industry Activities and Recognition

Fast Times at FDA: Explaining Accelerated Approval to Ridgemont High’s Jeff Spicoli
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, 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Sooner or Later, Everything Old is New Again: FDA Issues Draft Guidance Addressing Remanufacturing of Medical Devices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The Food and Drug Administration issued new draft guidance titled, “Remanufacturing of Medical Devices,” on June 17, 2021, with the goal of clarifying whether activities performed on medical devices are considered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 >

Fee Waivers for Small Businesses: Who Qualifies for the Small Business User Fee Waiver for Drugs and Biologics and How to Apply from an FDA and Corporate Perspective

Ensuring Compliance with FDA Cybersecurity Device Guidance: AGG Welcomes New Lateral Partner Lori L. Wright to Atlanta Office

AGG is pleased to welcome a new lateral partner and chair of the Technology, Commercial Contracting & Strategic Sourcing practice, Lori L. Wright. Lori has nearly fifteen years of experience working closely with healthcare purchasers to ensure appropriate security of medical devices and related “critical software.” She now brings this experience to assist medical device manufacturers in navigating a complex and evolving regulatory and commercial regime for cybersecurity. Lori advises clients on “security by design,” interoperability, software bill of materials (SBOM), and overall compliance with FDA guidance as it relates to security and technology. As the FDA continues to issue guidance and other measures to comply with the May 12, 2021 President’s Executive Order (EO) on Improving the Cybersecurity of the Federal Government (EO 14028), Lori is available to assist clients on compliance.To reach out to Lori, please click here.

Webinar Recording Available: Trends in the Regulation and Marketing of Hemp-Derived Products: CBD & Beyond

Carolina Wirth Joins Reed Tech’s Podcast as Guest Speaker on OTC Monograph User Fees

AGG Food & Drug of counsel Carolina M. Wirth joined David Wilson, senior account executive with Reed Tech, to discuss the new OTC drugs user fees program and answer some of the most frequently asked questions that they have encountered when working with clients in this space. OMUFA fees were due in May 2021 for Fiscal Year 2021. To listen to the recording, please click here. 

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