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The Camargo Blog

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


January 26th, 2010

505(b)(2) NDA Preparation Process

January 19th, 2010

DESI to 505(b)(2) Raises Drug Costs

January 15th, 2010

Could This NDA Delay Have Been Avoided?

January 11th, 2010

2009 505(b)(2) Approvals

January 11th, 2010

PhRMA Adds New Bio Companies

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 25th, 2009

505(b)(2)—Giving Thanks

November 22nd, 2009

EXAL-still-GO-ing

November 20th, 2009

Qutenza: Approval of a “DESI-inspired” Drug

November 16th, 2009

FDA Approves Xanodyne’s Tranexamic Acid

November 4th, 2009

A New Paradigm for the Development of Drugs for Type 2 Diabetes

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 27th, 2009

Did FDA Make a Mistake? Prodrug Emend Exclusivity Reconsidered

October 26th, 2009

FDA Reaffirms 5-year Exclusivity for a Prodrug

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

September 14th, 2009

A Treatment IND is NOT the Same as an IND

September 10th, 2009

Comparability Protocols

September 8th, 2009

DESI Presentation: Q&A

September 1st, 2009

Test Specifications for Stability Studies

August 24th, 2009

FDA Halts Marketing of Topical Ibuprofen Products

August 7th, 2009

FDA Requests Melamine Testing of Ingredients

July 31st, 2009

Colchicine Tablets Approved

July 29th, 2009

Scorecard of FDA Approvals Added

July 28th, 2009

BDSI’s Buccal Fentanyl 505(b)(2) NDA Approved

July 9th, 2009

Benzyl Alcohol—NME Approved Under 505(b)(2)

June 29th, 2009

Make the Most of Your Interactions With the FDA: FDA Meeting Requests

June 26th, 2009

Linking Preclinical (Safety), Clinical (Efficacy) and CMC (Quality) Development Activities

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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