Arnall Golden Gregory LLP's Food and Drug Newsletter is a monthly update of legal and regulatory issues that affect the FDA-regulated community, including regular updates on legislative initiatives from AGG’s Washington, DC office, and articles from members of AGG outside the Food and Drug Practice.
Industry Insights
FDA Issues Final Guidance on “505(q)” Citizen Petitions, including Factors to be considered in Evaluating Potential Anti-Competitive Behavior
By: Seth S. Ray and Christine Kirk
FDA recently issued final guidance for industry on citizen petitions and requests for stays of agency action that may delay the approval of certain drug and biological product applications. Companies planning to submit such petitions should review the recent guidance, Citizen Petitions and Petitions for Stay of Action Subject to Section 505(q) of the Federal Food, Drug, and Cosmetic Act (“505(q) Guidance”). The guidance addresses several items of potential interest to petitioners, such as: (i) FDA’s current thinking about when Section 505(q) applies, (ii) the interaction of petition review and the review of pending applications, and (iii) factors considered by the agency in determining whether a petition has been submitted for the primary purpose of delaying approval of an application, a practice known as “gaming” the petition process. We provide a brief summary of the guidance and note the larger context of FDA actions to prevent gaming of agency processes below. More >
FDA Releases Guidance on Acceptance Review for De Novo Classification Requests
By: Alan G. Minsk and Genevieve M. Razick
On September 9, 2019, the Food and Drug Administration released a final guidance document, Acceptance Review for De Novo Classification Requests, to clarify the content that companies need to include in de novo requests to meet a minimum threshold of acceptability for substantive review. The guidance is meant to create a more efficient product review process by encouraging better submissions. The guidance also provides FDA staff with a consistent approach for making an “Accept” or “Refuse to Accept” determination on a de novo request. The guidance includes both an Acceptance Checklist and a Recommended Content Checklist, both of which will be explained in further detail below. More >
“Made in the USA” Claims: The FTC is Considering Changes to Regulation and Enforcement
By: Alan G. Minsk and Christine Kirk
The U.S. Federal Trade Commission is considering changes to the regulation and enforcement of “Made in the USA,” “Made in USA,” and other U.S.-origin claims in labeling and advertising. The Commission held a public meeting on September 26, 2019, and is seeking stakeholder input as it considers potential changes. Comments are due by October 11, 2019. We provide a brief summary below. More >
