Webinar on Introduction to FDA Regulation of Combination Products
Overview:
A combination product is a product composed of any combination of a drug and a device; a biological product and a device; a drug and a biological product; or a drug, device, and a biological product.
Under 21 CFR 3.2 (e), a combination product is defined to include:
- A product comprised of two or more regulated components (i.e., drug/device, biologic/device, drug/biologic, or drug/device/biologic) that are physically, chemically, or otherwise combined or mixed and produced as a single entity;
- Two or more separate products packaged together in a single package or as a unit and comprised of drug and device products, device and biological products, or biological and drug products;
- A drug, device, or biological product packaged separately that according to its investigational plan or proposed labeling is intended for use only with an approved individually specified drug, device, or biological product where both are required to achieve the intended use, indication, or effect and where, upon approval of the proposed product, the labeling of the approved product would need to be changed (e.g., to reflect a change in intended use, dosage form, strength, route of administration, or significant change in dose); or
- Any investigational drug, device, or biological product packaged separately that according to its proposed labeling is for use only with another individually specified investigational drug, device, or biological product where both are required to achieve the intended use, indication, or effect.
Why should you Attend: To gain a fundamental understanding of FDA regulation of bioresearch monitoring.
Areas Covered in the Session:
- Definition of combination product
- FDA Regulatory Pathways
- Primary Mode of Action
- User Fee
Who Will Benefit:
- Regulatory professionals working in the field of combination products
Contact Detail:
Compliance4All DBA NetZealous,
Phone: +1-800-447-9407
Email: [email protected]
http://www.compliance4all.com/
Event Link :http://bit.ly/Introduction_to_FDA_Regulation_of_Combination_Products
Speaker and Presenter Information
Thomas E. Colonna earned a bachelor of science in microbiology from the University of Sciences in Philadelphia (formerly the Philadelphia College of Pharmacy and Science), a Ph.D. in molecular biology from the Johns Hopkins University, and a law degree from the Georgetown University Law Center. In addition, Dr. Colonna holds academic appointments at Johns Hopkins University and the University of Sciences in Philadelphia.
Event Type
Webcast
This event has no exhibitor/sponsor opportunities
When
Thu, Mar 31, 2016, 10:00am
PT
Website
Click here to visit event website
Organizer
NetZealous - Compliance4All
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@Compliance4all
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