Speaker Profile
Thomas E. Colonna
Founder, Biotech Consultant LLC
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.
Dr. Colonna provides consulting services in the scientific and regulatory aspects of a wide range of medical devices and biologics with particular expertise in the areas of in vitro diagnostics (ELISA-based, PCR-based, SNPs, microarrays, and pharmacogenomics), medical device software (including bioinformatics), and biotechnology-based products.
Dr. Colonna's consulting clients range from Fortune 500 companies to small start-up companies located throughout the US, as well as, Canada, India, and Russia. Widely published in numerous fields, Dr. Colonna brings a unique multidisciplinary approach to problem solving.
FDA Regulation of In Vitro Diagnostics
In vitro diagnostic devices, or IVDs, are assays designed to test body fluids for the presence of any substance of interest to researchers, clinicians, and healthcare providers. IVDs can be used to detect hormones or antibodies, viruses or expressed cancer genes, bacteria or bacterial resistance to antibiotics, and beyond. The Food and Drug Administration (FDA) has created a flexible, yet sometimes confusing, approach to IVD regulation.
Speaker: Thomas E. Colonna | View Anytime | Price: ¤189.00 | View Details
FDA Regulation of Combination Products
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.
Speaker: Thomas E. Colonna | View Anytime | Price: ¤189.00 | View Details
FDA Regulation of Dietary Supplements
FDA regulates both finished dietary supplement products and dietary ingredients. FDA regulates dietary supplements under a different set of regulations than those covering "conventional" foods and drug products.
Speaker: Thomas E. Colonna | View Anytime | Price: ¤189.00 | View Details
FDA Regulation of Medical Device Software
The Food and Drug Administration (FDA) was not empowered by Congress to regulate medical devices until May 28, 1976 when the Medical Device Amendments were added to the Federal Food, Drug, and Cosmetic Act (FDCA).
Speaker: Thomas E. Colonna | View Anytime | Price: ¤189.00 | View Details
Fundamentals on FDA Regulations of Bioresearch Monitoring
FDA's bioresearch monitoring program is a comprehensive, agency-wide program of on-site inspections and data audits designed to monitor all aspects of the conduct and reporting of FDA-regulated research. The BIMO Program was established in 1977 by a task force that included representatives from the drug, biologic, device, animal drug, and food areas.
Speaker: Thomas E. Colonna | View Anytime | Price: ¤189.00 | View Details
FDA Regulation of In Vitro Diagnostics
In vitro diagnostic devices, or IVDs, are assays designed to test body fluids for the presence of any substance of interest to researchers, clinicians, and healthcare providers. IVDs can be used to detect hormones or antibodies, viruses or expressed cancer genes, bacteria or bacterial resistance to antibiotics, and beyond. The Food and Drug Administration (FDA) has created a flexible, yet sometimes confusing, approach to IVD regulation.
Speaker: Thomas E. Colonna | View Anytime | Price: ¤134.00 | View Details
FDA Regulation of Combination Products
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.
Speaker: Thomas E. Colonna | View Anytime | Price: ¤138.00 | View Details
FDA Regulation of Dietary Supplements
FDA regulates both finished dietary supplement products and dietary ingredients. FDA regulates dietary supplements under a different set of regulations than those covering "conventional" foods and drug products.
Speaker: Thomas E. Colonna | View Anytime | Price: ¤137.00 | View Details
FDA's Bioresearch Monitoring (BIMO) Program Biologic, Device, Animal Drug, and Food Areas
FDA's bioresearch monitoring program is a comprehensive, agency-wide program of on-site inspections and data audits designed to monitor all aspects of the conduct and reporting of FDA-regulated research. The BIMO Program was established in 1977 by a task force that included representatives from the drug, biologic, device, animal drug, and food areas.
Speaker: Thomas E. Colonna | View Anytime | Duration: 60 Minutes | Price: ¤190.00 | View Details
FDA Regulation of Combination Products
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.
Speaker: Thomas E. Colonna | View Anytime | Price: ¤190.00 | View Details
FDA Regulation of Dietary Supplements
FDA regulates both finished dietary supplement products and dietary ingredients. FDA regulates dietary supplements under a different set of regulations than those covering "conventional" foods and drug products.
Speaker: Thomas E. Colonna | View Anytime | Price: ¤190.00 | View Details
Introduction to FDA Regulation of Combination Products
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.
Speaker: Thomas E. Colonna | View Anytime | Price: ¤190.00 | View Details
Combination Products: A Regulatory Perspective
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.
Speaker: Thomas E. Colonna | View Anytime | Price: ¤190.00 | View Details
FDA Regulation of Dietary Supplements
FDA regulates both finished dietary supplement products and dietary ingredients. FDA regulates dietary supplements under a different set of regulations than those covering "conventional" foods and drug products. Under the Dietary Supplement Health and Education Act of 1994 (DSHEA).
Speaker: Thomas E. Colonna | View Anytime | Price: ¤190.00 | View Details
FDA Regulation of Dietary Supplements
FDA regulates both finished dietary supplement products and dietary ingredients. FDA regulates dietary supplements under a different set of regulations than those covering "conventional" foods and drug products. Under the Dietary Supplement Health and Education Act of 1994 (DSHEA).
Speaker: Thomas E. Colonna | View Anytime | Duration: 60 Minutes | Price: ¤190.00 | View Details
The Dietary Supplement cGMP Rule (21 CFR part 111)
FDA regulates both finished dietary supplement products and dietary ingredients. FDA regulates dietary supplements under a different set of regulations than those covering "conventional" foods and drug products.
Speaker: Thomas E. Colonna | View Anytime | Price: ¤190.00 | View Details
FDA Regulation of Dietary Supplements
FDA regulates both finished dietary supplement products and dietary ingredients. FDA regulates dietary supplements under a different set of regulations than those covering "conventional" foods and drug products. Under the Dietary Supplement Health and Education Act of 1994 (DSHEA).
Speaker: Thomas E. Colonna | View Anytime | Price: ¤190.00 | View Details
FDA Regulation of Dietary Supplements
FDA regulates both finished dietary supplement products and dietary ingredients.
Speaker: Thomas E. Colonna | View Anytime | Duration: 60 Minutes | Price: ¤190.00 | View Details
Introduction to Biomedical Software Regulation
The Food and Drug Administration (FDA) was not empowered by Congress to regulate medical devices until May 28, 1976 when the Medical Device Amendments were added to the Federal Food, Drug, and Cosmetic Act (FDCA).
Speaker: Thomas E. Colonna | View Anytime | Duration: 60 Minutes | Price: ¤190.00 | View Details
Combination Products: A Regulatory Perspective
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.
Speaker: Thomas E. Colonna | View Anytime | Price: ¤390.00 | View Details
FDA Regulation of Dietary Supplements
FDA regulates both finished dietary supplement products and dietary ingredients. FDA regulates dietary supplements under a different set of regulations than those covering "conventional" foods and drug products. Under the Dietary Supplement Health and Education Act of 1994 (DSHEA).
Speaker: Thomas E. Colonna | View Anytime | Price: ¤390.00 | View Details
FDA Regulation of Dietary Supplements
FDA regulates both finished dietary supplement products and dietary ingredients. FDA regulates dietary supplements under a different set of regulations than those covering "conventional" foods and drug products. Under the Dietary Supplement Health and Education Act of 1994 (DSHEA).
Speaker: Thomas E. Colonna | View Anytime | Duration: 60 Minutes | Price: ¤390.00 | View Details
The Dietary Supplement cGMP Rule (21 CFR part 111)
FDA regulates both finished dietary supplement products and dietary ingredients. FDA regulates dietary supplements under a different set of regulations than those covering "conventional" foods and drug products.
Speaker: Thomas E. Colonna | View Anytime | Price: ¤390.00 | View Details
FDA Regulation of Dietary Supplements
FDA regulates both finished dietary supplement products and dietary ingredients. FDA regulates dietary supplements under a different set of regulations than those covering "conventional" foods and drug products. Under the Dietary Supplement Health and Education Act of 1994 (DSHEA).
Speaker: Thomas E. Colonna | View Anytime | Price: ¤390.00 | View Details
FDA Regulation of Dietary Supplements
FDA regulates both finished dietary supplement products and dietary ingredients.
Speaker: Thomas E. Colonna | View Anytime | Duration: 60 Minutes | Price: ¤390.00 | View Details
Introduction to Biomedical Software Regulation
The Food and Drug Administration (FDA) was not empowered by Congress to regulate medical devices until May 28, 1976 when the Medical Device Amendments were added to the Federal Food, Drug, and Cosmetic Act (FDCA).
Speaker: Thomas E. Colonna | View Anytime | Duration: 60 Minutes | Price: ¤390.00 | View Details