Regulatory Updates

23

Feb'18

USFDA completed its Inspection at Sun Pharma’s Halol Facility with Three Observations

The Company informed in its’s update that the US FDA conducted a Good Manufacturing Practices (GMP) inspection of Sun Pharmaceutical …

Read More

22

Jan'18

FDA Releases Agenda for New & Revised Guidances for Year 2018

For year 2018, Centre for Drug Evaluation and Research (CDER) of USFDA is Planning to Published New & Revised Draft …

Read More

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 …

Read More

05

Jan'17

US FDA issued warning letter to Wockhardt’s Ankleshwar plant.

US FDA issues a warning letter to Wockhardt for significant violations in manufacturing practice norms, including its Data Integrity issues, …

Read More

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 …

Read More

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   …

Read More

06

Feb'15

FDA warning letters-2015 on Data Integrity Issues

FDA issued two warning letters in January 2015 relating to Data Integrity Data integrity is essential requirement in a pharmaceutical …

Read More

24

Dec'14

Rapivab (Peramivir) got US FDA Approval

On December 19, the U.S. Food and Drug Administration approved Rapivab (Peramivir) to treat influenza infection in adults. Influenza, commonly …

Read More
Pharma Learners Copyright 2017, All rights reserved.
Skip to toolbar