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The Camargo Blog

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

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 12th, 2009

ANDA Suitability Petition vs 505(b)(2)

June 4th, 2009

Melphalan—New 505(b)(2) Orphan Designation

June 4th, 2009

Risk Evaluation Mitigation Strategy (REMS) for Long-Acting Opioids

May 29th, 2009

MAP Pharmaceuticals 505(b)(2) Dihydroergotamine Orally Inhaled Product Meets Phase 3 Goals

May 15th, 2009

Quick-release Bromocriptine Mesylate Approved

May 11th, 2009

Multiple Dosage Strength Products—CMC Considerations

April 1st, 2009

FDA Stops DESI Unapproved Rx Narcotics

March 23rd, 2009

What to Develop?

February 18th, 2009

Use of Data from Foreign Clinical Studies for US Approval

January 15th, 2009

505(b)(2) NDA Labeling

September 15th, 2008

505(b)(2) Literature Searches—Too Much or Too Little?

August 22nd, 2008

Modeling Using Dissolution Data

July 20th, 2008

Current versus RLD Approval Requirements

July 15th, 2008

PREA and 505(b)(2)

June 7th, 2008

Indevus’ Stock Drops 70% on FDA’s Request for More Safety Data

June 1st, 2008

What’s the Competition?

May 4th, 2008

Racemate > Isomer Approval Under 505(b)(2)

May 2nd, 2008

505(b)(2) RLD Patent Certification

January 16th, 2008

505(b)(2)—Part 2: The Assessment: Timeline, Cash Flows

December 24th, 2007

New Safety Reporting Requirements for Unapproved OTC Products

December 12th, 2007

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

December 7th, 2007

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

Page 4 of 5

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

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