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The Camargo Blog

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October 3rd, 2011

Don’t Launch Unapproved Products After 9/19/2011

September 11th, 2011

AB Rated 505(b)(2)’s

June 9th, 2011

Patent Cliff Causes Pfizer Cuts

June 8th, 2011

Role of In Vitro / In Vivo Metabolism Studies in 505(b)(2) Drug Development of Metabolite Products

June 2nd, 2011

Ophthalmics: 21 CFR 314 94(a)(9)(iv) No Longer Applies

June 2nd, 2011

Why Generic Companies Might Like 505(b)(2)

May 31st, 2011

K-V’s Makena: Part 3: Use of Public Information for 505(b)(2) Approvals

May 18th, 2011

K-V’s Makena® Part 1: 505(b)(1) or 505(b)2)?

May 16th, 2011

K-V’s Makena®: A trove of 505(b)(2) Lessons

March 23rd, 2011

Revised Safety Reporting for BE/BA Studies Effective March 28, 2011

March 10th, 2011

User Fee Waivers: What is an Affiliate? New Guidance Issued

February 21st, 2011

Approvals of ANDAs Slows

February 1st, 2011

Injectables: 505j or 505(b)(2)?

January 19th, 2011

REMS for 505(b)(2) Products?

January 6th, 2011

2010 505(b)(2) Approvals

December 20th, 2010

PDUFA Fee Waiver: Plan Ahead

October 18th, 2010

Company Officials Personally Liable

October 15th, 2010

When is an IND Required?

October 6th, 2010

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

August 31st, 2010

Failed 505(b)(2)?: Vivus™ Qnexa

August 23rd, 2010

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

August 4th, 2010

New User Fees for 2011

August 1st, 2010

Still Submitting Paper ANDA Applications?

July 12th, 2010

Advisory Committee Meeting: Rosiglitazone

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


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