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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.

May 7th, 2019

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

November 8th, 2018

Market Assessment:

August 1st, 2018

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

June 27th, 2018

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

May 2nd, 2018

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

April 11th, 2018

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

March 7th, 2018

Key Questions You Must Ask Before Hiring a Drug Development Consultant

February 15th, 2018

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

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

May 3rd, 2017

What Went Wrong? Important Considerations for Studies Outside the United States

April 26th, 2017

Abuse-Deterrent Opioids—The Insider’s Guide to Innovation and Exclusivity in a Changing Regulatory Landscape

April 19th, 2017

Special Protocol Assessment: Is It Important for Your Drug Development Program?

April 12th, 2017

Getting Cannabis-related Products Approved: the 505(b)(2) 4-20 Projects

March 29th, 2017

DESI Drugs: Potential Targets for Quick Approvals

March 22nd, 2017

Fixed-Dose Combination Products—Navigating the Combination Rule

March 15th, 2017

505(b)(2) Approval Times: The Real Scoop

February 22nd, 2017

Demystifying Orange Book Designations: The New Referencing Approved Drug Products in ANDA Submissions Draft Guidance

February 15th, 2017

Referencing a Listed Drug for the 505(b)(2) Pathway

January 10th, 2017

On the Rise: 2016 505(b)(2) NDA Approvals

December 14th, 2016

A New Indication for an Old Drug. What Could Go Wrong?

December 5th, 2016

Dramatically Decrease Drug Development Costs Through Literature-Only 505(b)(2) NDA Submissions

October 27th, 2016

505(b)(2) Application Changes: What You Need to Know

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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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