rna - regulatory news alert (volume 3 issue 1) january 2015

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NEWS ALERT REGULATORY 2 3 3 3 4 VOLUME 03 ISSUE 01 JANUARY 2015 PAGES 04 US FDA TIGHTENS REGULATORY NOOSE ON INDIAN DRUG FIRMS Import alert on Ranbaxy's Mohali unit; Strides' injectible arm gets Warning Letter ELI LILLY BUYS NOVARTIS UNIT FOR $5.4BN LUPIN GETS FDA APPROVAL FOR A GENERIC HIV DRUG INSIDE ISSUE THIS REGULATORY NEWS ALERT

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Page 1: RNA - Regulatory News Alert (Volume 3 Issue 1) January 2015

NEWS ALERT REGULATORY

2 33 34

VOLUME 03 ISSUE 01 JANUARY 2015 PAGES 04

US FDA TIGHTENS REGULATORY NOOSE ON INDIAN DRUG FIRMSImport alert on Ranbaxy's Mohali unit ; Strides' injectible arm gets Warning Letter

ELI LILLY BUYS NOVARTIS UNIT FOR $5.4BNLUPIN GETS FDA APPROVAL FOR A GENERIC HIV DRUG

INSIDEISSUETHIS

REGULATORY NEWS ALERT

Page 2: RNA - Regulatory News Alert (Volume 3 Issue 1) January 2015

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Dr. H. G. Shivakumar ♦ Dr. T. M. Pramod KumarDr. Balamuralidhara V. ♦ Dr. M. P. Venkatesh

Ms. Shilpi Khattri

HAPPY TWENTY FIFTEEN!

Student EditorsMr. Akshay Anand M. ♦ Ms. Gayathri Raju

EDITORIAL

DCGI’S NEW YEAR MESSAGE“2015 would be the year for streamlining of

Regulatory Procedures without compromising Patient Safety”

Dr. G. N. SinghDrug Controller General of India

RNA Vol 03 Issue 01 - January 2015

FDA APPROVES CLINICAL PROTOCOL TO TREAT EBOLA

NIH AND FDA WIN TOP AWARD STRIDES ARCOLAB GETS USFDA NODFOR CALCITRIOL SOFTGEL CAPSULES

e team with Dr. Pramod Kumar and Dr. Balamuralidhara at APTICON 2014

Page 3: RNA - Regulatory News Alert (Volume 3 Issue 1) January 2015

3CIPLA GETS `1,100 CR SOUTH AFRICAN ORDER FOR HIV TREATMENT DRUGS

MYLAN SELECTED AS LEADING SUPPLIERS OF ARV MEDICATIONS

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SUVEN LIFE GETS 5 NEW PRODUCT PATENTS

HEALTH MINISTRY ISSUES DRAFT NATIONAL HEALTH POLICY 2015

AUROBINDO TO ACQUIRE NATROL FOR $132 MN BIOCON TO SET UP UNIT IN VIZAG

Page 4: RNA - Regulatory News Alert (Volume 3 Issue 1) January 2015

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NR AR E G U L A T O R Y A L E R T N E W S

NEWSLETTER PUBLISHED BYPHARMACEUTICAL REGULATORY AFFAIRS GROUPDEPARTMENT OF PHARMACEUTICSJSS UNIVERSITY COLLEGE OF PHARMACYMYSURU, KARNATAKA - 570015

PAGE LAYOUT AND DESIGN BY AKSHAY ANAND M. SC

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[email protected]

OBAMA SIGNS SPECIAL EBOLA INCENTIVE PROGRAM INTO LAW CATAMARAN ACQUIRES SALVEO

FIRST STEM-CELL THERAPY RECOMMENDED FOR APPROVAL IN EUFDA APPROVES NEW ANTIBACTERIAL DRUG ZERBAXA

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