Postmarketing Safety Reporting for Combination Products Final Rule Effective January 19, 2017

Last month we reported that FDA Publishes Final Rule for Postmarketing Safety Reporting for Combination Products. This month, we wish to remind you that it has taken effect. The new rule “describes the postmarketing safety reporting requirements that apply when two or more different types of regulated medical products (drugs, devices, and/or biological products, which…

FDA Issues Final Guidance: Public Notification of Emerging Postmarket Device Signals

FDA Law Blog recently reported that “Approximately one year ago, on New Years Eve [2015], FDA surprised the device industry with a draft guidance on emerging postmarket device signals. On December 14 [2016], FDA issued the final guidance document: Public Notification of Emerging Postmarket Device Signals (“Emerging Signals”) FDA has made significant changes to the draft…

FDA Issues Two Important New Biosimilar Guidances

January 17, 2017: “FDA released Draft Guidance for Industry: “Considerations in Demonstrating Interchangeability With a Reference Product.” The guidance provides an overview of important scientific considerations in demonstrating interchangeability and is intended to assist applicants in demonstrating that a proposed therapeutic protein product (e.g., monoclonal antibodies) is interchangeable with a reference product under section 351(k)…

Seven Noteworthy 505(b)(2) Submissions

Seven Noteworthy 505(b)(2) Submissions

As drug and device consultants, the scientists and regulatory experts at PDG® spend a considerable amount of time working on 505(b)(2) NDA submissions. This paper highlights notable features of a cross section of recent 505(b)(2) approvals and provides a variety of everyday issues to consider as you contemplate your next drug development project. Generic companies…