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.
Allan M. Green
Allan M. Green is a physician, lawyer, and research scientist with operating management experience.
Dr. Green was formerly medical director of New England Nuclear/Dupont Medical Products and was subsequently founding CEO of Theseus Medical Imaging Inc. He served as President of Neuroptix, Inc.. He has served on various government committees as a technical consultant and has held several medical school appointments and is the author of many scientific papers in biochemistry and drug development. He is well known for his Issues and Commentary series that analyzes competitive commercial aspects and potential markets for emerging pharmaceutical technologies. He has successfully represented many American and Canadian clients in their relationships with the FDA and has organized a number of multi-disciplinary conferences on healthcare, pharmaceutical and funding issues. In addition, he is an attorney and has been 'of counsel' to major law firms with established healthcare practices.
Dr. Green received his B.S. in economics in 1966 and his Ph.D. in biochemistry and metabolism in 1971, both from the Massachusetts Institute of Technology. He received his M.D. from Case Western Reserve University School of Medicine in 1972 and holds Board certification in both Internal Medicine and in Nuclear Medicine. He received his J.D. from Boston College Law School in 1991.
He has published over 30 articles in peer-reviewed Scientific Journals and holds several US Patents.
Joseph P. Cascio
Joe Cascio is a highly experienced cGMP manufacturing operations and facilities construction management executive with a comprehensive and diverse background in establishing and directing the operations of biotechnology and biopharmaceutical companies and managing the technical and administrative activities of hospital laboratories and blood banks.
He has served in senior level management capacities and technical consulting roles during his career and has an extensive background in cGMP facility design, certification, validation, start-up and fill/finish operations. He directed the construction, opening and operations of 26 cGMP facilities, of which 20 were new and 6 were renovations.
He is adept at providing compliance support for cGMP, QA/QC, regulatory and accrediting agency requirements. He has provided assistance with cGMP compliance issues, FDA manufacturing issues, cGMP auditing, technology transfer, technical project management, SOP and protocol development, cGMP training program design and implementation, contract negotiation, lease and purchase of equipment, supplies procurement and materials management.
Joe holds a Masters in Immunohematology and a Bachelor of Science in Medical Technology in addition to certification and licensure as a Blood Bank Specialist and a Clinical Laboratory Scientist.