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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 5th, 2009

2008 505(b)(2) Approvals

January 27th, 2009

New (Draft) Guidance on Standardized Numerical Identification (SNI) for Drug Products

December 23rd, 2008

What is a ‘483?

December 16th, 2008

What is an NME?

December 3rd, 2008

505(b)(2) Combination Meets Phase 3 Goals

October 31st, 2008

Sertraline + CBT—a New 505(b)(2) Combo

September 17th, 2008

FDA Bans 30+ Ranbaxy Generic Drugs—Except 1 Sole Source

September 16th, 2008

More DESI-Products Cited. Exceptions are Noted for Unique Products.

September 15th, 2008

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

August 7th, 2008

Residual Solvents—New FDA Draft Guidance

August 4th, 2008

$1,247,200 PDUFA Fees for FY 2009

July 20th, 2008

Current versus RLD Approval Requirements

July 15th, 2008

PREA and 505(b)(2)

June 10th, 2008

Raptor Announces Orphan Designation for Cysteamine Bitartate

June 7th, 2008

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

June 4th, 2008

Fenofibrate in the News (Again)

May 18th, 2008

Paragraph IV Certifications Under 505(b)(2)

May 4th, 2008

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

May 2nd, 2008

505(b)(2) RLD Patent Certification

May 2nd, 2008

Trade Secrets

January 30th, 2008

505(b)(2—Part 3: Pre-IND Submission & Meeting

January 10th, 2008

FDA Takes Action Against Compounding Pharmacies’ Estriol-Containing Hormone Products

January 10th, 2008

PDUFA 2008—New Submisison Fees for 505(b)(2) Applications

December 24th, 2007

New Safety Reporting Requirements for Unapproved OTC Products

Page 9 of 10


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


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