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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.


September 1st, 2016

Effects on Exclusivity: The Biologics Price Competition and Innovation Act of 2009

August 24th, 2016

Improving Drug Development ROI in 2017

August 18th, 2016

Leveraging Postmarketing Safety Data in 505(b)(2) Drug Development Programs

July 6th, 2016

Tropical or Rare Pediatric Disease Priority Review Vouchers: Update and Use of the 505(b)(2) Pathway

June 21st, 2016

The GRAS is Not Always Greener

May 31st, 2016

Back to Basics: 505(b)(2) FAQs Part 2: Clinical and Nonclinical Studies

May 16th, 2016

Back to Basics: 505(b)(2) FAQs Part 1

April 27th, 2016

Statistical Bootstrapping Method to Take the Uncertainty out of Drug Development

April 20th, 2016

Fixed-Combination Drug Products: Are Phase 2 and 3 Studies Really Necessary?

April 14th, 2016

Faster Approval of Combination Drug Products via the 505(b)(2) Pathway

April 6th, 2016

Product Ideation: Identifying Your Optimal Drug Development Candidate

March 23rd, 2016

Pediatric Applicability or Not—This Revised Guidance is for You

March 14th, 2016

Additional 505(b)(2) Benefits: Selective Safety Data Collection

February 4th, 2016

2015 505(b)(2) NDA Approvals

January 27th, 2016

3-Year Exclusivity May Not Be Worth as Much as You Think

January 24th, 2016

Drug Development Question? Here’s How to Communicate With the FDA!

December 15th, 2015

New Nonclinical Guidance for 505(b)(2) Products: No Cause for Alarm

October 7th, 2015

The Winding Path to De-Risking Formulation Changes

September 22nd, 2015

Encounters of the Third Sector

September 13th, 2015

Enforcement Activities: FDA Removes Unapproved Prescription Ear Drops

August 25th, 2015

Examining the Amarin VASCEPA Saga

August 10th, 2015

A Review of the Regulatory History of Azelaic Acid and the Changing Requirements at FDA

July 21st, 2015

Use of Extrusion-Enabled Pharmaceutical Processes in Drug Development via a Streamlined Regulatory Pathway

July 20th, 2015

Final Rule—Drug Shortage Regulation: Incentive for Development of “Unapproved” Drugs?

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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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