Back to On-demand Program: FDA Hot Topics: 2015 Update on Medical Device Guidances
5.00 RAC

On-demand Program: FDA Hot Topics: 2015 Update on Medical Device Guidances

An on-demand recording of the RAPS Virtual Program, FDA Hot Topics: 2015 Update on Medical Device Guidances originally recorded on 9 September 2015.


Credits:
5.00 RAC

  • List Price: $695.00
  • Member Price: $495.00

 
Want to save more?
to see if you qualify for a lower rate.
Members: save $200.00 or more
Item Details:

So much has transpired in the last year with the Food and Drug Administration (FDA) that it is hard to keep up with all the new initiatives represented in a myriad of new agency guidance documents. Join RAPS, Wednesday 9 September, with industry-leading speakers in a half-day virtual program to...

Back to On-demand Program: FDA Hot Topics: 2015 Update on Medical Device Guidances
View More

» View the Table of Contents

Fundamentals of US Regulatory Affairs, Eighth Edition

Table of Contents

Section I: General Information
Chapter 1 FDA and Related Regulatory Agencies
Chapter 2 History of Food, Drug and Cosmetic Law
Chapter 3 Overview of Drug, Biologic and Device Regulatory Pathways
Chapter 4 FDA Communications and Meetings
Chapter 5 Preparing for Key FDA Meetings and Advisory Committee Meetings
Chapter 6 Crisis Management
Chapter 7 Health Technology Assessment
Chapter 8 Good Laboratory Practice Regulations
Chapter 9 Clinical Trials: GCPs, Regulations and Compliance
Chapter 10 Current Good Manufacturing Practice and Quality System Design