Wednesday, September 30, 2009

FDA Releases Proposed Guidance On Combination Products

Updated April 25, 2017

You might also be interested in:
FDA - Combination Products Guidance Documents

Root Cause Analysis & Deviation Investigation Report Writing - cGMP Training
Our most popular course
Qualstar - Pharmaceutical Simulation - Advanced cGMP Training
Put fun back into GMP training!

- -  original post follows below  - -

This Federal Register notice announces the FDA release of a proposed rule on combination products, Current Good Manufacturing Practice
Requirements for Combination Products (pdf)
. According to the FDA Law Blog post, FDA Issues Proposed Rule on cGMPs for Combination Products:

The proposed rule does not independently establish new requirements, rather, it clarifies which set of existing cGMP regulatory requirements apply when drugs, devices, and biological products are combined to create a combination product.
Return Home: The Health, Drug, Prescription, and GMP Supersite Blog

SkillsPlus Intl Inc. - The best GMP training, best QSR training, best instructors
Who Offers Live Onsite GMP Training?
SkillsPlus Intl Info Blog

The Designated Rep and Exemptee Professionals Blog
The Health, Drug, Prescription, and GMP Supersite Gift Store 

Trackback url:

No comments:

From SkillsPlus International Inc.

Custom Search

Even More Resources, Books, & Things (many from

    GMP Training Gifts & Giveaways