Article archive

New Publication on Recent Developments of Biosimilar Products

31/03/2013 22:50
New Publication on Recent Developments of Biosimilar Products The article "Biosimilar Development: The Race to Market Continues" written by Fiona M Greer of SGS gives a quite detailed update on development and market opportunities of biosimilar products. This article introduces the concept of...

"No Acceptance Testing during Method Transfer" cited in FDA 483

31/03/2013 22:49
"No Acceptance Testing during Method Transfer" cited in FDA 483 FDA expects firms to perform acceptance testing of analytical methods in the receiving laboratory when validated method are transferred between laboratories. The transfer and acceptance testing should follow formal transfer procedures....

FDA Answers Questions related to User Fees for Generic Drugs

31/03/2013 22:48
FDA Answers Questions related to User Fees for Generic Drugs From 2013 on generic drug and API manufactures must pay an annual users fee. Now FDA has disclosed the fee amounts on its website. A domestic FDF (fixed dose formula) facility has to pay: $175,389, foreign FDF facility: $190,389, domestic...

India issues guidelines for Certification of API exports to EU - Will EMA accept this certification ?

31/03/2013 22:13
  The European Union (EU) has reformed the rules for importing into the EU active substances for medicinal products for human use. As of 2 January 2013, all imported active substances must have been manufactured in compliance with standards of good manufacturing practices (GMP) at least...

CONDUCTING AN EFFECTIVE MEETING

16/03/2013 22:50
  A good presentation on   CONDUCTING AN EFFECTIVE MEETING.   Its very useful to understand the effectiveness of meeting and conducting meeting effectively....        

Why is GMP so important - Answers from the FDA **NEW**

16/03/2013 20:59
  Why is GMP so important - Answers from the FDA Why is GMP so important? This question is answered by the FDA in an article on facts about cGMPs. The FDA gives the answers in a compact form in 6 paragraphs on two pages. Read more.        

Final GDP Guideline published by EU Commission **NEW**

16/03/2013 20:52
The long awaited EU GDP Guideline was published in the Official Journal of the European Union by EU Commission on 7 March 2013. This document will replace the current GDP Guideline published in 1994 (94/C 63/03). The draft version was issued in July 2011 for public consultation. EMA received a...

GMP Regulations- Worldwide

03/03/2013 20:08
GMP Regulations    

"G.ONE" (GMP-ONE)- One Spot for all GMP Links required in our Jeevan

03/03/2013 20:06
"G.ONE" (GMP-ONE)- One Spot for all GMP Links required in our JEEVAN      

Patents & Trade mark web sources

02/03/2013 16:51
  www.patentlens.net Patent Lens is a worldwide, open-access, free full-text patent informatics resource. USA patents: Home page: https://www.uspto.gov/ Patents Search page : https://patft.uspto.gov/ UK patents: Home Page: https://www.ipo.gov.uk/ Patents Search page :...
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