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FDA Issues Final Guidance on Form and Content of Unique Device Identifier Labeling System

USA - July 26 2021 The UDI Rule’s standardized identification system is intended to allow healthcare professionals, patients, FDA and other users to rapidly identify a…

Coleen W. Hill, Patrick C. Gallagher, Ph.D.

New FDA Guidance Embraces "Remote Interactive Evaluations" but Stops Short of Permitting Virtual 704(a) Inspections

USA - April 19 2021 As the guidance makes clear, what FDA calls a “remote interactive evaluation” is “not the same as an inspection” under Section 704(a) of the Federal…

Patrick C. Gallagher, Ph.D., Justin M. L. Stern

FDA's Additional Draft Guidance on Biosimilarity and Interchangeability to Seek Comments and Suggestions by January 19, 2021

USA - December 11 2020 This guidance, when finalized, will facilitate the development of biosimilar and interchangeable products as FDA intends. The U.S…

Patrick C. Gallagher, Ph.D., Jiazhong (Jason) Luo, Ph.D.

Guidance for Formal Meetings Between FDA and ANDA Applicants of Complex Products Under GDUFA II

USA - December 3 2020 In GDUFA II, the FDA agreed to product development meetings, which provide for substantive discussions of specific scientific…

Alexandra Lane, Patrick C. Gallagher, Ph.D.

HHS OIG Issues Rare Special Fraud Alert Addressing Speaker Programs

USA - November 30 2020 In line with OIG’s advice, device and pharmaceutical companies should fully consider the risks associated with in-person speaker…

Erin M. Duffy, Kristine Murphy Gallagher