About

It is often said that, when it comes to understanding FDA regulation, an ounce of history is worth a pound of reason. FDA oversight is based on fairness and consistency; and both of those virtues demand a “level playing field” for all participants. Thus, the rules that have been used in the past generally are those that will be used going forward. The purpose of this site is to help you to know them.

The timeline from basic research and development through commercialization for life science companies is largely constrained by FDA regulations. The regulated activities, however, are those chosen by companies as best suited for demonstrating the safety and efficacy of their technology in specific clinical settings. FDA regulations set boundaries and hurdles for reaching Company goals. Regulatory strategic planning allows developers of new drugs and devices to progress toward objectives that they themselves set. The law firm of Allan M. Green, MD, PhD, JD, LLC provides support for these activities.

We advise clients on strategies for:

• Obtaining FDA approval to manufacture, investigate and market products
• Acquiring pharmacoeconomic data in support of full and fair reimbursement
• Dealing with disputes that arise before, during or after the approval process
• Assisting in determining the requirements for IND and IDE submissions
• Planning human clinical trials required for marketing clearance
• Planning, contracting, conducting and interpreting of the results of clinical trials
• Optimizing the terms and conditions of marketing approvals
• Good clinical practice and good manufacturing practice compliance problems
• Preparation of life sciences technology licensing and R&D agreements.

For companies and their investors, we conduct informed, third-party assessments of plans, timelines and practices in FDA-regulated industries.

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Principals