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Before electronic filing, a single NDA submission …. |
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Original Business Thinking for the Life Sciences |
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Allan M. Green, MD, PhD, JD, LLC Attorney at Law |
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FDAregs.com is the web site of Allan M. Green, MD, PhD, JD, LLC. Dr. Green and his associates focus on issues faced by FDA-regulated industries. We offer FDA regulatory support, as well as strategic business planning services and independent due diligence assessment of technology and program strategy.
We are committed to using our experience in law and business, as well as clinical medicine and scientific research to assist stakeholders in translational research—that is, moving new findings from the research bench to the clinic. With deep life science industry expertise, our goal is to provide our clients with knowledge and experience to allow more informed strategic business planning and capital investment in the life sciences sector.
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.
For more information e-mail us at amgreen@fdaregs.com
Our Insights and Commentary on issues of importance to the life science sector are published on this site. Please use the buttons on the left to explore our current offerings. |
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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. |
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