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The Camargo Blog

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

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

March 8th, 2017

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

March 1st, 2017

Camargo Counsel: The Cost of Wrong

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

February 8th, 2017

Clinical Trials with Multiple Endpoints: Pitfalls and Management

February 1st, 2017

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

January 25th, 2017

Electronic Submissions Update: End of FDA Paper Submissions Looms and What It Means

January 18th, 2017

Unforced Errors: FDA Refusal to File or Receive Letters

January 10th, 2017

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

January 5th, 2017

Improvements and Updates to the FDA Inactive Ingredient Database

December 20th, 2016

Improving NDA Approval Odds for New Dosage Forms of Approved Products

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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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