Tools for Understanding Drug Regulatory Process in USA

At the onset of New Year, 2012 I was pleasantly surprised to see a new look of  FDA's website where the browsing through the contents was a pleasure. You may be wondering, why I post many articles related to Drug Regulatory Process in USA ? Understanding Drug regulatory process in USA is a easy task , thanks to the various tutorials and tools offered by FDA and its affiliated websites. In this post I will give the links in FDA and its affiliated website where we could get useful tools for understanding Drug Regulatory Process in USA.

The tools and resources are as follows-

1. CDER Learn
CDER Learn has the following course list-

• CDER World

• The Past, Present, and Future of FDA Human Drug Regulation

• Bringing an Unapproved Drug Into Compliance 

• Risk assessment and communication

• FDA Medwatch and Patient Safety 

• Field Investigators: Adverse Drug Effects (ADE) Investigators (2000)

• The FDA Process for Approving Generic Drugs  

• An Introduction to the Improved FDA Prescription Drug Labeling  

2. FDA Drug Compliance

• The website http://fdadrugcompliance.com/ mainly talks about bringing an unapproved Drug into compliance, various approval pathways.

• The courses are taught through a video interface .

• There is also a knowledge check section .

3. Information for Industry (Drugs)

This section provides the resources related to drugs, ranging from the guidances , types of applications, drug approvals and databases etc.

4. FDA Voice

This is a recent addition to the FDA's website where the FDA's senior leadership and staff  write regarding various current topics of interest.

Hence, I  believe there is no point in wasting money for buying books and other resources for understanding Drug Regulatory Process in the USA. Of course, it is my personal opinion. I think that EMA and other advanced regulatory authorities could come up with learning tools on the lines of CDER learn etc to understand drug regulatory processes in their respective regions.

Note: 

1.Click on the  name of the tools or resources highlighted in red to directly go to the web page of FDA/its affiliate website. For example-CDER Learn (or) you could alternatively click on the references which I have Provided below.

2. There could be other useful resources provided by the FDA.

Keywords : CDER Learn, FDA Drug Compliance, Information for Industry (Drugs), FDA Voice.  

References-

http://www.fda.gov/Training/ForHealthProfessionals/default.htm

http://fdadrugcompliance.com/

http://www.fda.gov/Drugs/ResourcesForYou/Industry/default.htm

https://blogs.fda.gov/fdavoice/