Law Offices of Runan Zhang represents clients in a limited practice of Food and Drug Administration (FDA)-related activities covering the various products regulated by FDA. Many of our clients have come to us for advice on the most challenging problems requiring innovative approaches and intricate issues to achieve the desired result.

We advise clients on complying with FDA regulations and assist with drafting and responding to petitions. Our experience includes the following:

A. Advising companies about all aspects of FDA regulations, guidance, policies and procedures regarding foods, drugs and medical devices.

B. Developing the legal and factual premises and drafting petitions to the FDA seeking regulatory changes, interpretation or guidance, as well as policy-related actions.

C. Conducting "due diligence" and counseling in connection with FDA-related aspects of mergers and acquisitions, private equity transactions and asset purchases involving pharmaceutical, medical device and food manufacturers.

D. Advising food retailers and manufacturers on labeling requirements and on new requirements related to bioterrorism.

E. Advising medical device manufacturers on whether 510(k) s or PMAs are required, preparing 510(k) s and assisting medical device manufacturer clients with promotional materials