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DRAFT FDA GUIDELINES - IAGIM REVIEWED

Guideline - #1
FDA Draft Guidelines for Generic & Innovative Drugs
Reviewed by IAGIM Scientific Committee.

Impurities in New Drug Products - Q3B(R)
Guideline - #2
FDA Draft Guidelines for Generic & Innovative Drugs
Reviewed by IAGIM Scientific Committee.
BA and BE Overview - General Considerations
Guideline - #3
FDA Draft Guidelines for Generic & Innovative Drugs
Reviewed by IAGIM Scientific Committee.

Impurities in New Drug Substances - Q3A(R)

Guideline - #4
FDA Draft Guidelines for Generic & Innovative Drugs
Reviewed by IAGIM Scientific Committee. Download FDA/Journal Guide Now
.
Guideline - #5
FDA Draft Guidelines for Generic & Innovative Drugs
Reviewed by IAGIM Scientific Committee. Download FDA/Journal Guide Now
.
Guideline - #6
FDA Draft Guidelines for Generic & Innovative Drugs
Reviewed by IAGIM Scientific Committee. Download FDA/Journal Guide Now
.
Fax Amendments

Guideline - #7
FDA Draft Guidelines for Generic & Innovative Drugs
Reviewed by IAGIM Scientific Committee.
Download FDA/Journal Guide Now.
Alternative Active Suppliers
Guideline - #8
FDA Draft Guidelines for Generic & Innovative Drugs
Reviewed by IAGIM Scientific Committee. Download FDA/Journal Guide Now
.
August
Guideline - #9
FDA Draft Guidelines for Generic & Innovative Drugs
Reviewed by IAGIM Scientific Committee. Download FDA/Journal Guide Now
.
September

Guideline - #10
FDA Draft Guidelines for Generic & Innovative Drugs
Reviewed by IAGIM Scientific Committee. Download FDA/Journal Guide Now
.
October
Guideline - #11
FDA Draft Guidelines for Generic & Innovative Drugs
Reviewed by IAGIM Scientific Committee. Download FDA/Journal Guide Now
.
November
Guideline - #12
FDA Draft Guidelines for Generic & Innovative Drugs
Reviewed by IAGIM Scientific Committee. Download FDA/Journal Guide Now

December


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