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Blog & Resources Camargo Blog 505(b)(2) Development

The Camargo Blog

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


March 3rd, 2010

Exalgo Approved

February 11th, 2010

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

February 5th, 2010

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

February 4th, 2010

Once Daily Trazodone Approved

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 11th, 2010

PhRMA Adds New Bio Companies

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

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 3rd, 2009

FDA Refuse to File: Merck Zetia & Pfizer Lipitor

November 2nd, 2009

FDA Warns P&G Over Use of Drug + Vitamin C

October 30th, 2009

Reference Listed Drugs (RLDs): Can More Than One Be Used?

October 29th, 2009

REMS or RiskMAP or What?

October 28th, 2009

505(b)(2) Submissions: No RLD

October 26th, 2009

Preemption: New Hampshire 1, Sanity 0

October 20th, 2009

505(b)(2) for Formulation Changes

Page 6 of 10


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