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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 8th, 2018

Market Assessment:

January 25th, 2017

Electronic Submissions Update: End of FDA Paper Submissions Looms and What It Means

September 29th, 2016

Importing Investigational Pharmaceuticals to the U.S.? Changes Are Coming

May 23rd, 2016

Drug Repositioning: Bringing New Life to Shelved Assets and Existing Drugs

March 24th, 2015

Opportunities in Orphan Drug Development for Investors, Pharma and CROs

December 18th, 2014

The Potential Unveiling or Unraveling of Dormant Therapies—15-Year Data Exclusivity for Drugs for Unmet Needs

December 10th, 2014

Therapeutic Equivalence Ratings Under 505(b)(2)

November 24th, 2014

Orphan Drug Exclusivity for a Previously Approved Drug: a 505(b)(2) Conundrum

June 30th, 2014

Importing Pre-Launch Products with a Bit of PLAIR

April 8th, 2014

The Road to Commercial Success—The Target Product Profile

February 23rd, 2014

Top Generic CEO’s Confirm Importance of 505(b)(2) in Their Company’s Financial Future

January 19th, 2014

2013 505(b)(2) NDA Approvals

July 26th, 2013

PREA—Pediatric Plan Timing Changed by PDUFA V

May 28th, 2013

505(b)(2) Prodrug Fails Phase III Study

May 9th, 2013

Don’t Conduct Unneeded Tox Studies

April 18th, 2013

Nonclinical Bridging—Most 505(b)(2)’s Don’t Require Full Tox Package

April 10th, 2013

New PDUFA V Meeting Timelines

March 25th, 2013

Are 505(b)(2)’s “Super Generics” or What Do We Call Them?

January 2nd, 2013

2012 505(b)(2) Approvals—Record Year

December 16th, 2012

Suit to Challenge Use of REMS to Block Generics and 505(b)(2)

September 25th, 2012

New Generic Stability Requirements

April 15th, 2012

Drug Development Planned Like the Titanic

April 12th, 2012

NIH Head Urges Repositioning/Repurposing

December 21st, 2011

What is an Approved DESI Product?

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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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