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The Camargo Blog

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

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?

September 25th, 2012

New Generic Stability Requirements

September 11th, 2011

AB Rated 505(b)(2)’s

June 14th, 2011

K-V’s Makena Part 4: Statistical versus Clinical Significance

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

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

May 18th, 2011

K-V’s Makena® Part 1: 505(b)(1) or 505(b)2)?

May 16th, 2011

K-V’s Makena®: A trove of 505(b)(2) Lessons

March 10th, 2011

User Fee Waivers: What is an Affiliate? New Guidance Issued

February 21st, 2011

Approvals of ANDAs Slows

January 6th, 2011

2010 505(b)(2) Approvals

October 6th, 2010

505(b)(2)s with Minimal Sponsor Studies

August 23rd, 2010

Lannett’s Morphine Sulfate Oral Solution: 505(b)(2) or 505j?

August 20th, 2010

Generic Lovenox: 505j or 505(b)(2)

May 14th, 2010

Target Product Profile

April 23rd, 2010

Manufacturing Problems for Intravenous Emulsions

March 10th, 2010

FDA’s DAARP is now DAAP, DPAP is now DPARP

March 2nd, 2010

Do Not Neglect Your Third-Party Drug Substance Manufacturer

Page 2 of 5

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

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