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 >

AGG Partner Brian A. Teras and Associate Joel N. Gosser will present a complimentary webinar "Money, Money, Money: Raising Capital and Exit Transactions for Life Sciences Companies" on October 3rd.

AGG Partner Kevin Coy will speak at the Endpoint Clinical's User Group Meeting presenting on GDPR, Brexit and European Union and United States Privacy Shield Issues in London on October 9th.

AGG Partner Alan G. Minsk will participate in the Emory University Center for Ethics Consensus Conference on the issue of Preclinical Pharmaceutical Research and Treatment on October 10th and 11th. The conference is supported by a grant from both PhRMA and the PhRMA Foundation.

AGG Partner Alan G. Minsk will present a FDANews' webinar "Patient Prescription Drug Labeling" on October 29th.

AGG Partner Alan G. Minsk will speak at the AUTM Asia 2019 presenting on "Winning the Lottery: Revenue vs. Broader Social Impact and the Role of Licensing Today" at Ramanda Wyndham in Jerusalem, Israel on November 4-7th.