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The Camargo Blog

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

August 31st, 2010

Failed 505(b)(2)?: Vivus™ Qnexa

August 23rd, 2010

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

August 23rd, 2010

Will We Have Generic User Fees? Public Meeting to Be Held.

August 20th, 2010

Generic Lovenox: 505j or 505(b)(2)

August 4th, 2010

New User Fees for 2011

August 1st, 2010

Still Submitting Paper ANDA Applications?

July 15th, 2010

Avandia: Who Won?

July 12th, 2010

Advisory Committee Meeting: Rosiglitazone

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

Page 6 of 10

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

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