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SR NO
Name
FileName
1
Twelve New Drug Advisory Committees (NDAC) ( 27 Jul 2012 )
newdrug advisory commitee.pdf
2
Drugs approved for Marketing in India( 27 Jul 2012)
Drugs approved for Marketing in India
3
Guidelines on Common Technical Document (CTD) (New Drug Application -NDA ( 27 Jul 2012 )
CTD Guidance Final.pdf
4
System of preliminary scrutiny by C.D.S.C.O at the time of receipt of application for approval of Fixed Dose Combinations ( 27 Jul 2012 )
Fixed dose Combin.pdf
5
Draft Guidelines For Industry on Reporting Serious Adverse Events occurring in Clinical Trials ( 27 Jul 2012 )
Guidance for New Drug Approval 23.07.2011.pdf
6
Draft Guidance for Industry on requirement of Chemical & Pharmaceutical Information including Stability Study data before Approval of Clinical Trials / BE Studies ( 27 Jul 2012 )
Guidance CMC Stability Data.pdf
7
Report of Prof. Ranjit Roy Chaudhury Expert Committee
Report_of_Dr_Ranjit_Roy.pdf
8
Cellular Biology Based Therapeutic Drug Evaluation Committee (CBTDEC)
cellular biology.pdf
9
Approved for Marketing in India
New Drugs approval updated 2013 (4).doc
10
Permission to Market in India
Sec_122_A.htm
11
Draft Guidance for Industry on Fixed Dose Combinations
FDC Guidelines_Revised1.pdf
12
Clarification with respect of the manufacturing and marketing of New Drugs - regarding
clarification_new_drugs_10_3_2010.pdf
13
Draft guidance on approval of clinical trials & new drugs
Guidance_for_New_Drug_Approval-23.07.2011.pdf
14
Circular Regarding Approval of Safety and Efficacy Marketed in the Country of FDC Without Approval from DCG(I)
Circular Regarding Approval of Safety and Efficacy Marketed in the Country of FDC's Without Approval from DCG(I).pdf