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

http://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/ucm468246.htm?source=govdelivery&utm_medium=email&utm_source=govdelivery

 

CDRH  Public Workshop – In Vitro Diagnostic Testing for Direct Oral Anticoagulants, October 26, 2015

Learning Objectives

• Analytical performance requirements for the diagnostic assessment of direct oral anticoagulants (DOACs – Coumadin^®, Pradaxa^®, Xarelto^®, Eliquis^®, Savaysa^®)
• Clinical circumstances for testin
•  Topics:
  • 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
• http://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/ucm459448.htm?source=govdelivery&utm_medium=email&utm_source=govdelivery

 

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

http://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/ucm459449.htm?source=govdelivery&utm_medium=email&utm_source=govdelivery

 

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.

Botanical Review Team

Guidance for Industry: Botanical Drug Products

Guidance for Industry: Botanical Drug Development..