By Evan B. Siegel
A step by step, built-in strategy for profitable, FDA-approved mix drug products
utilizing a confirmed built-in method of blend drug improvement, this e-book courses you step-by-step via the entire preclinical, medical, and production phases. Written from an FDA regulatory viewpoint, the e-book not just allows you to carry a winning mixture drug product to industry, it additionally units forth the most productive and powerful route to FDA approval.
The e-book starts with an introductory bankruptcy featuring definitions and simple regulatory rules of mixture items. subsequent, it stories production and controls, preclinical trying out types, pharmacology, medical checking out, regulatory submissions, FDA reports, and approvals. one of the key issues tested are:
* The pharmacology, safeguard pharmacology, and toxicology helping human medical trials of mix products
* ways to scientific trial protocol layout and execution
* Chemical, physicochemical, and analytical features of producing controls and validation that result in strong parts for mixture products
* Key sponsor/FDA conferences and negotiations crucial for approval and commercialization
Case reviews regarding such real mixture items as Mylotarg, Herceptin, and HercepTest assist you larger know how to enforce the author's useful instructions. References on the finish of every bankruptcy help you locate additional info on any degree of the improvement, production and approval processes.
This ebook is perfect for researchers, regulators, lecturers, venture managers, and bosses inquisitive about the advanced strategy of mix product improvement. not just does itoffer a accomplished advisor to the technical elements of the sector, it additionally integrates all ofthese technical features right into a unified, powerful method of support be sure a winning, licensed product.Content:
Chapter 1 review of mixture items improvement and Regulatory assessment (pages 1–4): Evan B. Siegel
Chapter 2 precise Regulatory techniques to improvement, assessment, and Approval (pages 5–75): James Barquest
Chapter three Nonclinical strategies for winning Characterization and improvement of blend Drug items (pages 77–111): Duane B. Lakings
Chapter four scientific Pharmacology and scientific improvement of mix items (pages 113–170): Chaline Brown
Chapter five Regulatory technique issues for Chemistry, production, and Controls: An built-in technique (pages 171–200): Patrick L. DeVillier
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Extra info for Development and Approval of Combination Products: A Regulatory Perspective
FDA advises that informal jurisdictional determinations are not binding on the Agency, so if there are questions or uncertainty regarding the appropriate jurisdictional assignment, a formal RFD should be submitted. 7 The Request for Designation (RFD) Process The RFD process is described in 21 CFR Part 3. When the jurisdiction of a combination or noncombination product is unclear or in dispute, a formal RFD may be submitted to OCP. Sponsors intending to submit an RFD are encouraged to submit it as soon as they believe that there is sufficient information for FDA to make a decision regarding assignment of product jurisdiction.
If the sponsor has specific questions or concerns with regard to jurisdiction or regulatory path, they should be discussed with FDA at this time. FDA advises that informal jurisdictional determinations are not binding on the Agency, so if there are questions or uncertainty regarding the appropriate jurisdictional assignment, a formal RFD should be submitted. 7 The Request for Designation (RFD) Process The RFD process is described in 21 CFR Part 3. When the jurisdiction of a combination or noncombination product is unclear or in dispute, a formal RFD may be submitted to OCP.
Gene therapy products). 44 DETAILED REGULATORY APPROACHES TO DEVELOPMENT, REVIEW, AND APPROVAL † To maintain regulatory consistency. For example, for a device co-packaged with a drug covered by new drug product exclusivity, a separate NDA or ANDA may be necessary for the drug component. The number of marketing applications that FDA may require or that the sponsor would like to submit should be included among the topics covered in early discussions with FDA. Sponsors should keep in mind that the regulation of combination products is evolving as FDA deals with new issues presented by innovative combination products.