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The Camargo Blog

Get insight and information from our team of experts to improve your pharmaceutical development and commercialization strategy.


February 21st, 2011

Contrave® Rejection: The Long and the (Too) Short of It

January 6th, 2011

2010 505(b)(2) Approvals

November 4th, 2010

Safety Studies for 505(b)(2) Applications

October 6th, 2010

505(b)(2)s with Minimal Sponsor Studies

August 23rd, 2010

Lannett’s Morphine Sulfate Oral Solution: 505(b)(2) or 505j?

August 20th, 2010

Generic Lovenox: 505j or 505(b)(2)

June 25th, 2010

India Tightening Inspections on Raw Materials

May 14th, 2010

Target Product Profile

April 23rd, 2010

Manufacturing Problems for Intravenous Emulsions

March 10th, 2010

FDA’s DAARP is now DAAP, DPAP is now DPARP

March 2nd, 2010

Do Not Neglect Your Third-Party Drug Substance Manufacturer

March 2nd, 2010

Proposed FDA Rule Would Make Sponsors More Responsible for Data Integrity: Way More Responsible

February 11th, 2010

Can and Should ANDA Labeling Differ from the RLD?

February 11th, 2010

Roche’s Actemra Approved for RA After Year’s Delay

February 4th, 2010

Once Daily Trazodone Approved

February 3rd, 2010

It’s Budget Time at the FDA!

January 27th, 2010

Morphine Sulfate Oral Solution-Roxane is First Across the 505(b)(2) Finish Line

January 15th, 2010

Could This NDA Delay Have Been Avoided?

January 13th, 2010

Competition for 505(b)(2) Approvals

January 11th, 2010

2009 505(b)(2) Approvals

January 7th, 2010

Analytical Requirements for Oral Solutions

January 4th, 2010

Start Your New Year Right

December 22nd, 2009

Getting Unapproved Drugs (DESI, etc.) Approved

December 21st, 2009

Questions and Answers on the Topic of Authorized Generics

Page 3 of 6


Camargo Pharmaceutical Services provides comprehensive drug development solutions, specializing in customized programs including the 505(b)(2) pathway.


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