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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.


May 7th, 2013

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

May 5th, 2013

Raptor’s Procysbi Costs More Than A Generic (!)

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

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 26th, 2012

Orphan Designation without Exclusivity: Court Asked to Decide

August 8th, 2012

K-V Pharma Bankrupt—Claims FDA Doesn’t Back Makena

June 18th, 2012

REMS in Congress

April 19th, 2012

ViroPharma Denied Request for 3-year Exclusivity

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?

October 3rd, 2011

Don’t Launch Unapproved Products After 9/19/2011

September 11th, 2011

AB Rated 505(b)(2)’s

August 7th, 2011

2012 PDUFA User Fees

June 24th, 2011

Whew! Supreme Court Rules Generic Labels Must Track RLD

June 9th, 2011

Patent Cliff Causes Pfizer Cuts

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

June 2nd, 2011

Why Generic Companies Might Like 505(b)(2)

May 31st, 2011

K-V’s Makena: Part 3: Use of Public Information for 505(b)(2) Approvals

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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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