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The Camargo Blog

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December 7th, 2007

505(b)(2)—Part 2: The Assessment: Clinical Pharmacology

December 1st, 2007

505(b)(2)—Part 2: The Assessment: Pharmacokinetic Review

November 19th, 2007

New MAPP for FDA Accepting Alternate Compendia for CMC Standards

November 16th, 2007

505(b)(2) Combo Plavix/Prilosec

November 12th, 2007

505(b)(2)—Part 2: The Assessment: Preclinical Review/Preclinical Plan

November 8th, 2007

505(b)(2)—Part 2: The Assessment: Safety Review

November 8th, 2007

P&G Drops Out of a 505(b)(2) Development

November 6th, 2007

505(b)(2)—Part 2: The Assessment: Efficacy Review

November 5th, 2007

505(b)(2)—Part 2: The Assessment: Competitive Product(s) Review

November 5th, 2007

Foreign Inspections by FDA

November 1st, 2007

505(b)(2)—Part 2: The Assessment: Overview

October 30th, 2007

505(b)(2)—Part 1: The Overall Process

October 30th, 2007

Adams “DESI” Product Approvable

October 28th, 2007

505(b)(2)—Freedom from Generic Competition—Exclusivity Issues

October 16th, 2007

Drug Repositioning: 2 Flavors

October 8th, 2007

First Generic FDA Review Time to Drop

September 28th, 2007

FDA Moving Against Unapproved Hydrocodone Products

September 27th, 2007

CNN Story on “Unapproved Drugs”

September 21st, 2007

PDUFA 2007—New Submisson Fees for 505(b)(2) Applications

September 14th, 2007

505(b)(2) of Withdrawn Product

September 14th, 2007

Inactive Ingredients Exposed

September 14th, 2007

Use CMO’s Labs or Outside Labs

September 13th, 2007

MDS Bioanalytical Audits

Page 10 of 10

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

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Durham NC, 27713
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