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Blog & Resources Camargo Blog Regulatory

The Camargo Blog

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


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 26th, 2010

505(b)(2) NDA Preparation Process

January 15th, 2010

Could This NDA Delay Have Been Avoided?

January 7th, 2010

Analytical Requirements for Oral Solutions

January 4th, 2010

Start Your New Year Right

December 22nd, 2009

505(b)(2) Approval Standards—Referenced Studies

December 22nd, 2009

Getting Unapproved Drugs (DESI, etc.) Approved

December 21st, 2009

Questions and Answers on the Topic of Authorized Generics

December 12th, 2009

PCID Summary

November 22nd, 2009

EXAL-still-GO-ing

November 20th, 2009

Qutenza: Approval of a “DESI-inspired” Drug

November 4th, 2009

Does Europe Have a Pathway for Approval of Drugs Analogous to the FDA’s 505(b)2 Pathway?

November 4th, 2009

GTx Needs a 2nd Phase III Trial and More Safety Data

November 3rd, 2009

FDA Refuse to File: Merck Zetia & Pfizer Lipitor

November 2nd, 2009

FDA Warns P&G Over Use of Drug + Vitamin C

October 30th, 2009

Reference Listed Drugs (RLDs): Can More Than One Be Used?

October 29th, 2009

REMS or RiskMAP or What?

October 28th, 2009

505(b)(2) Submissions: No RLD

October 26th, 2009

Preemption: New Hampshire 1, Sanity 0

October 20th, 2009

505(b)(2) for Formulation Changes

October 14th, 2009

Codeine Sulfate: FDA Continues Drive to Remove Unapproved Products, With a Twist

October 8th, 2009

Allergan Sues FDA to Allow Off-Label Promotion

September 30th, 2009

Biosimilars—An introduction

Page 7 of 10


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


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