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May 13th, 2019

505(b)(2) or ANDA: Which Pathway is Right for Your Product?

May 7th, 2019

2018 505(B)(2) Approvals in Review: Another Year of Double-Digit Growth

January 30th, 2019

The Shutdown from Camargo’s Perspective

December 7th, 2018

Scope of Orphan Drug Exclusivity -

November 8th, 2018

Market Assessment:

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 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

March 21st, 2018

Product Ideation: Who Wants to Develop a Successful Product?

March 14th, 2018

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

March 7th, 2018

Key Questions You Must Ask Before Hiring a Drug Development Consultant

February 28th, 2018

Two Investigational Applications for One Drug Product? IVD Device Requirements

February 15th, 2018

2017—A Great Year for Generics—Yes or No?

February 7th, 2018

The Hypertension Fixed-dose Combination Product Guidance: Straight from the 505(b)(2) Playbook

February 1st, 2018

Increase the Value of Your Prodrug Asset Under 505(b)(2): An Alkermes Program Update

January 24th, 2018

505(b)(2) Approvals for 2017: What Were They and Who Developed Them?

January 18th, 2018

505(b)(2) Success Requires More Than Just Science

January 16th, 2018

2017 505(b)(2) NDA Approvals Increase Dramatically and Review Times Decrease

January 10th, 2018

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

December 14th, 2017

Chemistry, Manufacturing, and Controls Requirements: Bridging and 505(b)(2)

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

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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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Phone 513.561.3329
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