Home | Welcome to Contract Pharma   
Last Updated Sunday, April 19 2015

Print

Search Results for 'fda'

Search For:
Refine by Dates:
From: To:
Past 7 Days        Past 30 Days
Refine By Content:

Contract Service Directory Companies

View All Companies »


Contract Service Directory Categories

View All Categories »


Search Results:

FDA Inspection Trends
By Michael Klapal, Drug Specialist - U.S. FDA
Published October 1, 2014
Topics: • Quality Agreements • Inspection Trends • Field Alert Reporting Trends… Read More »
Setting Up an FDA-Compliant Data Integrity Program
By John Avellanet, Cerulean Associates LLC
Published October 1, 2014
(What’s So Funny ‘Bout) Part 11 and Data Integrity Read More »
Published July 22, 2014
Will produce NME for U.S. market Read More »
Published April 24, 2014
Employs Novozymes' VELTIS technology for optimized dosing Read More »
By Gil Roth
Published December 10, 2013
Spokane CMO facility cited by agency Read More »
Published December 2, 2013
Regensburg site to manufacture four solid and semi-solid, high-potent products Read More »
By Tim Clark
Published February 29, 2012
An initial take on the Agency's proposal for biosimilars Read More »
Published February 27, 2012
An FDA-approved drug product to which new generic versions are compared to show that they are bioequivalent. A drug company seeking approval to market a generic equivalent must refer to the RLD in its ANDA. By designating a single RLD as the standard… Read More »
By Gary C. Messplay, J.D.
Published March 1, 2007
The Agency continues its revamp of cGMPs Read More »
By Dilip M. Parikh
Published August 22, 2005
Outsourcing offers companies a new option in this regulatory process. Read More »


Receive free Contract Pharma Direct emails
Sign up now to receive the weekly newsletter, and more!

Enter your email address:
Follow Contract Pharma On