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The Camargo Blog

Get insight and information from our team of experts to improve your pharmaceutical development and commercialization strategy.


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

October 25th, 2017

A Vitamin Approved as a Drug(!): Forget What You Think You Know to Be True

October 18th, 2017

Gaining New Indications with Real World Data: The 505(b)(2) Sweet Spot

October 13th, 2017

Not a Generic? Must Be a 505(b)(2)?

October 11th, 2017

Drug or Device?—FDA Provides More Clarity—Or Does It?

October 4th, 2017

Product Selection: Which Product to Develop?

September 27th, 2017

Seamless Clinical Trials: Why Didn’t We Think of That?

September 20th, 2017

The Race to Get a Cannabidiol Product Approved: Why Is It Taking So Long?

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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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