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.
Areas Covered in the Session:
- Definition of combination product
- FDA Regulatory Pathways
- Primary Mode of Action
- User Fees
Who Will Benefit:
- Regulatory professionals working in the field of combination products
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.
NetZealous - Compliance4All,
161 Mission Falls Lane, Suite 216,
Fremont, CA 94539, USA.
Event Link : http://bit.ly/1LLEDvl
Contact the event managers listed below for more information about how you can participate at the Webinar on FDA Regulation of Combination Products.
|Conference/Event Dates:||11/19/2015 - 11/19/2015|
|Other Industries:||Business, Clinical Pharmacology, Professional Healthcare, Sciences|
|Cost to Attend:||One Dial-in One Attendee Price: US$150.00|
|Audience:||Regulatory professionals working in the field of combination products|
|Booth Size||Booth Cost||Available Amenities|
|Marketing Vehicles Allowed:||n/a|
|Other Booth Sizes Available: n/a|
How do I show up here?
Add a note here, it is only visible by you.