Labeling/Advertising and Promotion, Import/Export, and Enforcement ActionsMichael Swit
Presentation to the Regulatory Affairs Certification (RAC) Review Course, sponsored by the Orange County Regulatory Affairs (OCRA) Discussion Group, on August 2, 2014, in Irvine, CA. See slides 4-58 for Labeling/Advertising Discussion; slide 59 to 72 for Imports/Exports, and 73 to end for Enforcement Actions
August 2, 2014 presentation to the Orange County Regulatory Affairs (OCRA) Discussion Group Regulatory Affairs Certification (RAC) Review Course, with a focus on:
• History of FDA
• Overview of US Legal System
• General Structure of FDA
• FDA Definitions
Herbal medicines are popular because of experience and the abundant
availability of plants in India due to its varied climatic zones. India has
around 45,000 species of plants, out of which 15,000–20,000 plants have
proven medicinal value.
Labeling/Advertising and Promotion, Import/Export, and Enforcement ActionsMichael Swit
Presentation to the Regulatory Affairs Certification (RAC) Review Course, sponsored by the Orange County Regulatory Affairs (OCRA) Discussion Group, on August 2, 2014, in Irvine, CA. See slides 4-58 for Labeling/Advertising Discussion; slide 59 to 72 for Imports/Exports, and 73 to end for Enforcement Actions
August 2, 2014 presentation to the Orange County Regulatory Affairs (OCRA) Discussion Group Regulatory Affairs Certification (RAC) Review Course, with a focus on:
• History of FDA
• Overview of US Legal System
• General Structure of FDA
• FDA Definitions
Herbal medicines are popular because of experience and the abundant
availability of plants in India due to its varied climatic zones. India has
around 45,000 species of plants, out of which 15,000–20,000 plants have
proven medicinal value.
This SlideShare gives an overview on how a drug is discovered, researched, developed, tested and reviewed for approval. It follows the current standard of approval set by the Food and Drug Administration (FDA), a federal agency of the United States Department of Health and Human Services. The process is generally divided into 4 Stages: Pre-Clinical, Clinical, New Drug Application (NDA) Review & Post-Marketing.
IND (Investigational New Drug) industrial perspectiveAYESHA NAZEER
Describing the Industry's/sponsor's/drug manufacturers' perspective of the Investigational New Drug Application (IND) program based on the survey conducted by the Office Of Inspector General (OIG).
A regulatory strategy is critical to the commercialization of biomedical technologies. In particular, technologies such as new drugs and medical devices have more regulatory needs, and the strategy should be considered simultaneous to a commercialization pathway.