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The Camargo Blog

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


June 29th, 2010

The Skinny On a Potential New Treatment of Obesity

June 10th, 2010

Labeling for Abuse-Deterrent Drugs

May 19th, 2010

Prodrug Denied

May 14th, 2010

Target Product Profile

April 30th, 2010

CMC Issues Again

April 23rd, 2010

Manufacturing Problems for Intravenous Emulsions

April 23rd, 2010

Oxycodone + Niacin Voted Down 19-1

April 21st, 2010

FDA Advisory Committee to Review Acura’s Oxycodone Plus Niacin; Risk/Benefit in Question

April 20th, 2010

505(b)(2): Repositioning, Repurposing or What?

March 26th, 2010

505(b)(2) Approvals

March 18th, 2010

FDA Removes Unapproved Nitroglycerin Tablets

March 12th, 2010

FDA’s Determination of Vyvanse as NME Upheld

March 10th, 2010

FDA’s DAARP is now DAAP, DPAP is now DPARP

March 3rd, 2010

Exalgo Approved

March 2nd, 2010

Do Not Neglect Your Third-Party Drug Substance Manufacturer

March 2nd, 2010

Proposed FDA Rule Would Make Sponsors More Responsible for Data Integrity: Way More Responsible

February 23rd, 2010

Spending on DTC Advertisements

February 20th, 2010

Generic Approvals Taking Longer

February 11th, 2010

Can and Should ANDA Labeling Differ from the RLD?

February 11th, 2010

Roche’s Actemra Approved for RA After Year’s Delay

February 8th, 2010

News on the Biosimilar Front

February 5th, 2010

Pediatric Assessments in Drug Development: Timing in Europe vs. US

February 4th, 2010

Once Daily Trazodone Approved

February 3rd, 2010

It’s Budget Time at the FDA!

January 27th, 2010

Morphine Sulfate Oral Solution-Roxane is First Across the 505(b)(2) Finish Line

January 26th, 2010

505(b)(2) NDA Preparation Process

January 19th, 2010

DESI to 505(b)(2) Raises Drug Costs

January 15th, 2010

Could This NDA Delay Have Been Avoided?

January 11th, 2010

PhRMA Adds New Bio Companies

January 7th, 2010

Analytical Requirements for Oral Solutions

January 4th, 2010

Start Your New Year Right

December 22nd, 2009

505(b)(2) Approval Standards—Referenced Studies

December 22nd, 2009

Getting Unapproved Drugs (DESI, etc.) Approved

December 21st, 2009

Questions and Answers on the Topic of Authorized Generics

December 12th, 2009

PCID Summary

November 25th, 2009

505(b)(2)—Giving Thanks

November 22nd, 2009

EXAL-still-GO-ing

November 20th, 2009

Qutenza: Approval of a “DESI-inspired” Drug

November 16th, 2009

FDA Approves Xanodyne’s Tranexamic Acid

November 4th, 2009

A New Paradigm for the Development of Drugs for Type 2 Diabetes

November 4th, 2009

Does Europe Have a Pathway for Approval of Drugs Analogous to the FDA’s 505(b)2 Pathway?

November 4th, 2009

GTx Needs a 2nd Phase III Trial and More Safety Data

Page 6 of 9


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


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