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The Camargo Blog

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

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?

September 13th, 2017

Navigating Clinical Holds

September 6th, 2017

De-Risking Drug Development

August 30th, 2017

Optimizing Your Global Drug Development Program: Strategy for Regional Variations of the 505(b)(2) Pathway

August 23rd, 2017

The Target Product Profile: Your Strategy to Reduce Development and Review Time

August 17th, 2017

Stability Requirements in the 505(b)(2) Space: Why, What, When, How

August 2nd, 2017

Deuterization: Is it Enough to Get 5- or 7-Year Exclusivity for a 505(b)(2) Product?

July 26th, 2017

Recent Developments for Abuse-Deterrent Opioids: FDA and Payers Influence Societal and Market Impact

July 19th, 2017

What Went Wrong? Make Sure Your Bridge Stays Intact, CMC and Dissolution

July 12th, 2017

Pre-IND Meetings: The Increasing Frequency of Written Responses Only, and Which FDA Divisions Use Them the Most

June 21st, 2017

PREA Requirements for Biosimilar and Interchangeable Biological Products

June 14th, 2017

A Green Card Is No Longer a “Green Light”—Changes to FDA Security Policy

June 7th, 2017

Brexit and EMA: The Changes Have Begun

May 24th, 2017

What Went Wrong? Important Outcomes of a Successful Pre-IND Meeting

May 17th, 2017

Due Diligence Assessment: Determining a Drug Product’s Potential Value

May 10th, 2017

The Value of a Strategic Assessment: Aligning for Success from the Start

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

April 5th, 2017

Shortening the Review Clock: the Latest on Priority Review Vouchers

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

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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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