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Last Updated on : 02/09/2016
You are here:  HOME | NEW DRUGS
NEW DRUGS

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Draft Guidance for Industry on requirement of Chemical & Pharmaceutical Information including Stability Study data before Approval of Clinical Trials / BE Studies ( 27 Jul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Draft Guidance for Industry on Fixed Dose Combinations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Draft guidance on approval of clinical trials & new drugs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

15 Updated Package Insert PI for empagliflozin Tablets 10mg and 25mg based on company Core Data Sheet (CCDS)  Pdf

 

 

 

 

 

 

 

 

 

 

 

 

 


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