CDRH Industry Basics Workshop – Purchasing Controls & Process Validation – November 4, 2015
- Understand the Intent and Background of Purchasing Controls
- Define Product, Component and Service
- Understand Purchasing Controls Requirements, Voluntary Guidance and Best Practices
- Recognize the Links between Purchasing Controls and other Quality System (QS) requirements such as Design Controls and Acceptance Activities
CDRH Public Workshop – In Vitro Diagnostic Testing for Direct Oral Anticoagulants, October 26, 2015
- Analytical performance requirements for the diagnostic assessment of direct oral anticoagulants (DOACs – Coumadin®, Pradaxa®, Xarelto®, Eliquis®, Savaysa®)
- Clinical circumstances for testin
- Impact of DOACs on traditional coagulation testing
- Clinical circumstances where testing would be relevant
- Clinically meaningful interpretation of coagulation testing
- Regulatory requirements for IVD for coagulation testing
CDRH Public Workshop – Standards Based Approach to Analytical Performance Evaluation of Next Generation Sequencing In Vitro Diagnostic Tests, November 12, 2015
Learning Objectives: Optimize FDA’s regulation of next-generation sequencing (NGS)-based in vitro diagnostic tests
- Analytical standards and approaches to develop or build on existing standardization efforts
- Use of regulatory science for performance standards for next generation sequencing in vitro diagnostic tests
CDER – SBIA CHRONICLES
Botanical Drug Review
- Foods, dietary supplements, drugs, medical devices, or cosmetics, depending on their “intended use.” ( advertising, labeling, distribution)
- Unique features: Complex mixtures, lack of a distinct active constituent(s), and substantial prior human use.
Regulation of Botanical Drugs
OTC Drug Monograph: Establishment of standards (monographs or non-monographs) for an OTC therapeutic drug category.
IND, NDA: For human testing and marketing approval the product for the proposed use. CMC Information: Often different from that for synthetic or highly purified drugs.