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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 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

November 8th, 2018

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

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

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

June 28th, 2017

Camargo Counsel: The New Reality of Generics under GDUFA

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Demystifying Orange Book Designations: The New Referencing Approved Drug Products in ANDA Submissions Draft Guidance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

August 24th, 2016

Improving Drug Development ROI in 2017

August 18th, 2016

Leveraging Postmarketing Safety Data in 505(b)(2) Drug Development Programs

July 6th, 2016

Tropical or Rare Pediatric Disease Priority Review Vouchers: Update and Use of the 505(b)(2) Pathway

June 21st, 2016

The GRAS is Not Always Greener

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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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