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The Camargo Blog

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Recent 505(b)(2) articles


December 7th, 2018

Scope of Orphan Drug Exclusivity—How Broad is Broad?

November 8th, 2018

Market Assessment: Is Your Product Going to Make It on the Market?

October 10th, 2018

“Breakthrough” the Barriers: Breakthrough Therapy Designation for 505(b)(2)

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?

September 12th, 2018

Looking for Clarification on Reporting Post-Approval Changes to a Drug Substance to the FDA? You are in Luck.

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?

August 1st, 2018

505(b)(2) Nonclinical Development: Examples and Advantages

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 27th, 2018

What Clinical Studies Are Needed for a 505(b)(2) Drug Development Project?

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

May 23rd, 2018

505(b)(2) Strategy for Biotech Execs: Positioning Your Products for Success, Q&A Part 1

May 16th, 2018

Getting Liposome Drug Products Approved: They Are Non-Biological Complex Drugs

May 2nd, 2018

New FDA Guidance Illustrates Breadth of 505(b)(2) Development Programs

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 29th, 2018

How to Get Orphan Status for 505(b)(2) 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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