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Blog & Resources Camargo Blog Regulatory

The Camargo Blog

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


June 14th, 2015

Active Ingredients vs. Active Moieties—Perplexity of Understanding the Relationship or Distinction

June 11th, 2015

To List or Not to List—That is the Question

March 24th, 2015

Opportunities in Orphan Drug Development for Investors, Pharma and CROs

March 11th, 2015

REMS/ETASU and Safe Use in Bioequivalence Trials

February 27th, 2015

MAPPing Out the Timing of a Complete Response Submission

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

September 22nd, 2014

Paper Submissions: Going, Going… Away

July 22nd, 2014

MannKind Breathes Easier—Inhaled Insulin Finally Approved

June 30th, 2014

Importing Pre-Launch Products with a Bit of PLAIR

April 8th, 2014

The Road to Commercial Success—The Target Product Profile

January 19th, 2014

2013 505(b)(2) NDA Approvals

July 30th, 2013

ANDA but No NDA—What to Rely On?

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

May 7th, 2013

Merck Uses 505(b)(2) for New Combo

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?

February 11th, 2013

No 5-Year Exclusivity for Combinations Drugs with an NCE

December 16th, 2012

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

September 26th, 2012

Orphan Designation without Exclusivity: Court Asked to Decide

September 25th, 2012

New Generic Stability Requirements

Page 4 of 10


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


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