April 2nd, 2020

COVID-19 Stimulus Legislation Will Cost OTC Manufacturers

March 26th, 2020

Emergency Use Authorizations: What Is an EUA, and Does Your Product Qualify?

March 3rd, 2020

2019 505(b)(2) NDA Approvals in Review

January 17th, 2020

Changes to Pediatric Study Plan Requirements for Oncology Drug Products Are Coming—Are You Prepared?

December 31st, 2019

Drug Development for an Aging Population

October 23rd, 2019

The Opportunity for Generics Companies and Value Added Medicines in the US and Europe

September 24th, 2019

3 Key Takeaways from the 25th Annual Charles River Biotech Symposium

August 22nd, 2019

Nonclinical Development Basics Part 1: The Right Nonclinical Strategy and Study Designs

August 13th, 2019

Rare and Orphan Drug Development in the EU

July 12th, 2019

The Missing Parts of the Inactive Ingredient Database (IID)

July 9th, 2019

ANDAs Prioritized to Combat Opioid Crisis

June 27th, 2019

Digital Health: FDA Regulation of Mobile Medical Apps

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?

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

9825 Kenwood Road
Suite 203
Cincinnati OH, 45242
Durham Office
800 Taylor Street
Suite 101
Durham NC, 27701
Montreal Office
507 Place d'Armes
Suite 1101
Montreal, QC H2Y 2W8, Canada
Phone 513.561.3329
Toll Free 888.451.5708
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