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Regulatory Affairs

06

Feb'18

Types of Patents, Exclusivity and Hatch-waxman Act.

At the time of fling an ANDA application (Generic drug application), an applicant must provide, information related to any patents …

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08

Jan'18

Drug Recalls

 What is a drug recall? Recall is an action taken to withdraw/remove the drugs from distribution or use in the …

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03

Jan'18

FDA 483 and Warning Letter

For the purpose of protecting public health and ensures compliance with the Food, Drug and Cosmetic Act, Food and Drug Administration …

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19

Feb'17

FDA Releases Agenda for New & Revised Guidances for Year 2017

In its Agenda Centre for Drug Evaluation and Research (CDER) is Planning to Published New & Revised Draft Guidances during …

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16

Feb'17

What is NDC Code (National Drug Code)

Q.What is NDC Code (National Drug Code)? The NDC, or National Drug Code, is a unique 10-digit, 3-segment number. It …

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02

Jan'17

List of Pharma Companies in India received Warning letters, Import Alert and NCR by USFDA and EDQM

List of Pharma Companies in India received Warning letters, Import Alert and Non-Compliance Reports issued by U.S. and European regulatory …

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05

Dec'16

DISCRIMINATORY DISSOLUTION METHOD

Discriminatory Dissolution Method Before starting about the discriminatory dissolution Method, let us understand about dissolution test in brief. Why dissolution …

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28

Nov'16

e-CTD best practices and PDF specifications for ANDA compilation:Comprehensive Tutorial

The e-CTD has a number of features that can speed up submission publishing and review times, including cross-application linking capabilities …

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01

Aug'15

Types of Marketing Authorization Procedures in Europe

There are mainly four procedures by which an applicant can obtained a marketing authorization in EU These are: Centralise Procedure …

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21

Jul'15

Variation filing in Europe

Types of variation filing in Europe   Here i have tried to explain variation filing procedures in Europe market as …

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15

Jul'15

FDA issues import alert for Emcure’s Pune plant

USFDA banned import from Emcure Pharma’s Pune plant over GMP issues   In a series of regulatory action against Indian …

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25

Jun'15

Dissolution Apparatus Types and their Applications as Per USP

Types of Dissolution Apparatus and their Applications as Per USP   Drug Dissolution Testing: In the pharmaceutical industry, drug dissolution testing …

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21

May'15

MSG (Mono sodium Glutamate ): is it safe?

Monosodium glutamate (MSG) is a food additive and is commonly used as a flavor enhancer in Chinese food, canned vegetables, …

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27

Mar'15

List of Code of Federal Regulations (CFR) related to BA/BE studies [With links]

About Code of Federal Regulations (CFR):   CFR is the codification of the general and permanent rules and regulations published in …

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08

Feb'15

USFDA New Guidances Publishing in 2015

Center for Drug Evaluation and Research(CDER) -FDA  is planning to publish, new and revised guidances in calendar year 2015   …

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