Home | Welcome to Contract Pharma   
Last Updated Friday, December 19 2014

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 »
FDA’s Friedman on Reliable Manufacturing, From Interphex 2014
By Agnes Shanley, Editor
Published March 20, 2014
At the PDA conference track at Interphex 2014 in New York City, Richard Friedman, Associate Director of FDA’s Office of Manufacturing & Product Quality, discussed what differentiates reliable from unreliable aseptic processes. Read More »
Published February 19, 2014
13 prequalified companies will participate in program to enhance security of imported drugs Read More »
By Gil Roth
Published December 10, 2013
Spokane CMO facility cited by agency Read More »
Published October 21, 2013
Goedheijt and Douwstra to head operations and production Read More »
Published March 25, 2013
Similar to Changes Being Effected (CBE). A filing with the FDA to gain approval of a moderate change, i.e., a change that has a moderate potential to have an adverse effect on the identity, strength, quality, purity, or potency of the drug product as… Read More »
Packaging Serialization Update
By Stephen Barlas, Contributing Writer
Published March 7, 2012
FDA reviews obsolete 2004 barcode rule 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 »

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

Enter your email address:
Follow Contract Pharma On