CDRH Workshops, CDER Botanical Drug Review – Drug and Device Digest

CDRH Industry Basics Workshop – Purchasing Controls & Process Validation – November 4, 2015

Learning Objectives:

  • 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

Learning Objectives


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



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.

Botanical Review Team

Guidance for Industry: Botanical Drug Products

Guidance for Industry: Botanical Drug Development..



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