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The Camargo Blog

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


April 1st, 2009

FDA Stops DESI Unapproved Rx Narcotics

March 30th, 2009

Botanicals: What is the Starting Material for the API?

March 23rd, 2009

Generic Cliff

March 23rd, 2009

What to Develop?

March 19th, 2009

One vs. Two Batches for Single-Dose and Multiple-Dose Studies

March 9th, 2009

505(b)(2) Development Risks

February 28th, 2009

Generic Biologics

February 18th, 2009

Use of Data from Foreign Clinical Studies for US Approval

February 5th, 2009

2008 505(b)(2) Approvals

February 2nd, 2009

Dexlansoprazole Approved for the Treatment of GERD

January 29th, 2009

Watson’s 505(b)(2) Overactive Bladder Gel Approved by FDA

January 27th, 2009

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

January 15th, 2009

505(b)(2) NDA Labeling

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

December 3rd, 2008

Brand Name Drugs No Better Than Generics

November 25th, 2008

Medicaid Paid for Unapproved DESI Drugs

October 31st, 2008

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

October 13th, 2008

Drug Repositioning Summit 2008

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?

September 2nd, 2008

Shionogi to Buy Sciele Pharma

September 2nd, 2008

Transcept and Novacea to Merge

August 22nd, 2008

Modeling Using Dissolution Data

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Residual Solvents—New FDA Draft Guidance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)

July 3rd, 2008

Hospira Expands Into 505(b)(2) Development

July 2nd, 2008

505(b)(2)—No Patent, Just Exclusivity

July 2nd, 2008

BIO—User’s Manual

June 15th, 2008

Creating a Safer NSAID

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)

June 1st, 2008

What’s the Competition?

May 27th, 2008

Multiple RLD’s Under 505(b)(2)

May 26th, 2008

RLD—Born in the USA

May 18th, 2008

Paragraph IV Certifications Under 505(b)(2)

May 14th, 2008

Biovail to Reduce 505(b)(2) Development

Page 8 of 9


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


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