FDA Regulatory law, in-vitro diagnostic regulatory law

News

Tobacco Products Scientific Advisory Committee (TPSAC) meeting 3-1-2012

On March 1st, 2012, the Tobacco Products Scientific Advisory Committee met to finalize their report on dissolvable tobacco products, and their impact in several areas including public health and on children’s health. Background: The TPSAC is an advisory panel within the FDA that was created by the Family Smoking Prevention and Tobacco Control Act (Public [...]

IVD Roundtable Notes

December 8, 2011 John Kahan of Hogan & Hartson gave an introductory speech. He pointed out that his firm represents over 700 device companies, work with every different division/office in CDRH, and that in his opinion, CDRH (including OIVD) has been behaving generally different from past years. Policies at CDRH have been changing, and the [...]

Summary of Hematology and Pathology Devices Panel Meeting

A summary of speeches and events.

Welcome

Located in the heart of one of the medical product innovation centers of the world, Longwell and Associates is a food and drug law practice that delivers proven strategic regulatory advice to US and international clients. By combining our experience and practical knowledge we assist all sized companies at any stage of development to navigate intricate laws and regulations.

We work in every area of food and drug law with the strength of the practice in devices, in vitro diagnostics, combination products and drugs. We handle a full array of issues ranging from development of regulatory and compliance strategies, preparation of documents and submissions, planning and execution of FDA meetings, establishing and auditing of systems, as well as diligence for investors for funding, licensing and acquisitions.