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The Camargo Blog

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


January 30th, 2019

The Shutdown from Camargo’s Perspective

September 26th, 2018

On the “Fast Track”: Fast Track Designations for Your 505(b)(2) Drug Development Program

September 19th, 2018

Are Botanical Drugs, Herbal Medicinal Supplements, and Natural Product Drugs 505(b)(2)s, Too?

August 23rd, 2018

FDA Firsts and Updates: Competitive Generics, Complex Generics, SiRNA Approval, and Closing the Orphan Loophole

August 15th, 2018

GDUFA I and II: Considerations for Complex Generics Innovators

August 8th, 2018

Orphan Exclusivity for ‘Same Drug’: What Has Changed Since FDARA 2017/ PDUFA VI?

July 25th, 2018

Innovative Thinkers: FDA Wants YOU

July 18th, 2018

The Importance of the Target Product Profile in 505(b)(2) Development

July 11th, 2018

Nonclinical Study Requirements for 505(b)(2) Development

June 20th, 2018

Europe’s Value Added Medicines Initiative

June 14th, 2018

Complete Response Letters (CRLs): Big Trouble for Small Pharma

May 30th, 2018

505(b)(2) Strategy for Biotech Execs: Positioning Your Products for Success, Q&A Part 2

April 25th, 2018

FDA Action on Exparel® Highlights the Importance of Letting the Data Drive the Story

April 18th, 2018

505(b)(1) versus 505(b)(2): They Are Not the Same

April 11th, 2018

Exclusivity GAINs Additional Indications: Advantages of QIDP Designation Paired with 505(b)(2) Strategy

March 14th, 2018

Why You Need Camargo’s Cutting-Edge Pharmacokinetics Team Involved in Your 505(b)(2) Program: Can We Really Do That?

January 10th, 2018

A 505(b)(2) Qualified Infectious Disease Product QIDP Designation—8 Years of Exclusivity

December 6th, 2017

Rx-to-OTC Switch: Expanding to the US Over-the-Counter Market

November 29th, 2017

How Will New FDA Guidance for Generic Abuse-Deterrent Opioids Pan Out?—An Update Based on the Final Guidance

November 17th, 2017

Complex Generics Getting Too Complicated for the Generic Approval Pathway? GDUFA II and the Pre-ANDA Program to the Rescue

November 13th, 2017

Get Your Pre-IND Meeting Done Right the First Time, and Other FDA Words of Wisdom

November 1st, 2017

Complex Generic Drug Products: A Changing Regulatory Landscape

October 25th, 2017

A Vitamin Approved as a Drug(!): Forget What You Think You Know to Be True

October 18th, 2017

Gaining New Indications with Real World Data: The 505(b)(2) Sweet Spot

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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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