Bioequivalence and Bioavailability Forum • Nonbinding Recommendations

bharathnadh.pharma
☆

India,
2014-06-25 14:09
(4383 d 06:47 ago)

Posting: # 13140
Views: 2,231

Nonbinding Recommendations [Regulatives / Guidelines]

Dear all,

good morning every one, iam fresher to this field. i have doubt about protocol preparation please suggest me.

while i preparing the protocol based on US-FDA gudelines i refered Nonbinding Recommendations (http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm075207.htm). but methazolamide not having Nonbinding Recommendations. i cant understand right now please suggest me. :confused:

thank you all

Helmut
★★★

Vienna, Austria,
2014-06-25 14:42
(4383 d 06:15 ago)

@ bharathnadh.pharma
Posting: # 13141
Views: 1,799

Nonbinding Recommendations

Post reply

Hi Bharathnadh,

❝ while i preparing the protocol based on US-FDA gudelines i refered Nonbinding Recommendations (http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm075207.htm). but methazolamide not having Nonbinding Recommendations. i cant understand right now please suggest me.

All of FDA’s recommendations are nonbinding. If you want to deviate, see this post (i.e., don’t submit such a study without controlled correspondence). If a drug is not listed in the product-specific guidances, the general ones are still applicable.

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