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The Camargo Blog

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

November 16th, 2016

PRO-CTCAE: Improving Oncology Drug Development

February 17th, 2016

Return on Investment for 505(b)(2) Products: Is an “AB” Rating Possible?

March 30th, 2015

Priority Review Vouchers are a Big Carrot for Hungry Companies

February 25th, 2015

Extending Exclusivity: How Long Will It Really Last?

October 28th, 2014

5-Year Exclusivity for Certain Fixed-Combination Drugs with an NCE

September 26th, 2014

Alkermes Prodrug for Treatment of Multiple Sclerosis: NCE?

July 22nd, 2014

MannKind Breathes Easier—Inhaled Insulin Finally Approved

July 26th, 2013

PREA—Pediatric Plan Timing Changed by PDUFA V

July 1st, 2013

FDA Goes Against Advisory Committee and Approves Low Dose Paroxentine for Hot Flashes

June 3rd, 2013

FDA Rejects Depomed’s Gabapentin for Menopausal Symptoms

April 9th, 2013

Advisory Committee Cool on Non-Steroid Hot Flash Treatments

September 11th, 2011

AB Rated 505(b)(2)’s

June 8th, 2011

Role of In Vitro / In Vivo Metabolism Studies in 505(b)(2) Drug Development of Metabolite Products

June 2nd, 2011

Ophthalmics: 21 CFR 314 94(a)(9)(iv) No Longer Applies

March 23rd, 2011

What is the Pediatric Drug Development Approach for Rare Diseases and Orphan Drugs?

February 21st, 2011

Contrave® Rejection: The Long and the (Too) Short of It

December 11th, 2010

Nuedexta®—Smart Pharmacology to Treat a Unique Disorder

June 29th, 2010

The Skinny On a Potential New Treatment of Obesity

May 14th, 2010

Target Product Profile

February 5th, 2010

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

November 4th, 2009

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

April 17th, 2009

505(b)(2) Program: BTG’s Paxclitaxel Gel for Oesophageal Cancer

July 15th, 2008

PREA and 505(b)(2)

June 5th, 2008

Suicidal Behavior: Ignore Therapeutic Area at Your Own Risk

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

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