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The Camargo Blog

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

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 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 12th, 2017

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

June 14th, 2017

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

May 24th, 2017

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

May 10th, 2017

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

April 26th, 2017

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

April 5th, 2017

Shortening the Review Clock: the Latest on Priority Review Vouchers

March 8th, 2017

Pre-IND Meetings: How to Achieve Success for 505(b)(2)

February 1st, 2017

Real-World Evidence: Can It Really Be Used for Drug Approvals?

January 18th, 2017

Unforced Errors: FDA Refusal to File or Receive Letters

December 20th, 2016

Improving NDA Approval Odds for New Dosage Forms of Approved Products

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

November 16th, 2016

PRO-CTCAE: Improving Oncology Drug Development

November 3rd, 2016

Expedited Approval of FDA-Approved Drugs in Australia

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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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