News

Summary of Hematology and Pathology Devices Panel Meeting

A summary of speeches and events. Read more

IVD Roundtable at the FDA, Jan. 13, 2010

At the FDA, the OBRR Director Jay Epstein welcomed us and introduced the first speaker, Sayah Nedjar, who gave us a CBER update. Read more

Marketing drugs or devices to health care providers? The national legal trend is “no more tchotchkes”.

As of today, seven states and the District of Columbia have enacted laws addressing marketing practices of pharmaceutical manufacturers, in terms of gifts and perks provided to their customers. Read more

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.