FDA: Guidance for Industry CFS/ME - nonbinding recommendations

[melamine]

http://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm388568.pdf

March 2014

Guidance for Industry Chronic Fatigue Syndrome/Myalgic Encephalomyelitis: Developing Drug Products for Treatment

Contains Nonbinding Recommendations Draft — Not for Implementation

This draft guidance, when finalized, will represent the Food and Drug Administration’s (FDA’s) current
thinking on this topic. It does not create or confer any rights for or on any person and does not operate to
bind FDA or the public. You can use an alternative approach if the approach satisfies the requirements of
the applicable statutes and regulations. If you want to discuss an alternative approach, contact the FDA
staff responsible for implementing this guidance. If you cannot identify the appropriate FDA staff, call the appropriate number listed on the title page of this guidance.

 

[Esther12]

Anything good or bad in it?

I have to admit, I misread the title I thought this was going to be all about nonblinded trials!

 

[beaker]

1. The
   
   
2. 25 FDA encourages sponsors to design clinical programs that fit their particular needs and to
   
   
3. 26 discuss their planned approach with the Division of Pulmonary, Allergy, and Rheumatology
   
4. 27 Products.

1. {my emphasis}
   
   I couldn't read all. But so far it sounds like they are on the ball.
   I remember their conference went well.
   Now they need to implement this and not just have it as a draft !!
   
   

 

[melamine]

I haven't read it all yet. It was something I had stumbled on while searching for something else and was rather pleasantly surprised.