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Blog & Resources Camargo Blog Regulatory

The Camargo Blog

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


October 27th, 2016

505(b)(2) Application Changes: What You Need to Know

October 18th, 2016

Extrapolation of Clinical Data for Pediatric Uses: Application for Medical Devices and Drug Products

October 13th, 2016

Effects on Combination Products: The Biologics Price Competition and Innovation Act of 2009

September 20th, 2016

Risk Evaluation and Mitigation Strategies (REMS) Basics

September 1st, 2016

Effects on Exclusivity: The Biologics Price Competition and Innovation Act of 2009

August 18th, 2016

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

August 9th, 2016

Pitfalls of Changing the Salt of a Listed Drug

August 2nd, 2016

Abuse Deterrence Labeling—Generic vs 505(b)(2) Drug Development

July 28th, 2016

The EU Regulatory Environment: National vs. Central Scientific Advice in the European Union

July 26th, 2016

Protein Product 505(b)(2)s Face a Looming Application “Dead Zone”

July 20th, 2016

Back to Basics: 505(b)(2) FAQs Part 4: Regulatory Strategies—Pharmacokinetic Studies

June 28th, 2016

The New FDA Draft Guidance on Chewables

June 21st, 2016

The GRAS is Not Always Greener

June 14th, 2016

Back to Basics: 505(b)(2) FAQs Part 3: Regulatory Strategies

June 6th, 2016

Key Inflection Point in a Drug’s Time to Market: Choice of Regulatory Pathway

May 4th, 2016

The Regulation of Follow-On Biological Products via 505(b)(2)

March 23rd, 2016

Pediatric Applicability or Not—This Revised Guidance is for You

March 21st, 2016

Is a Reference Listed Drug Mandatory in the 505(b)(2) Pathway?

January 24th, 2016

Drug Development Question? Here’s How to Communicate With the FDA!

September 13th, 2015

Enforcement Activities: FDA Removes Unapproved Prescription Ear Drops

August 25th, 2015

Examining the Amarin VASCEPA Saga

August 10th, 2015

A Review of the Regulatory History of Azelaic Acid and the Changing Requirements at FDA

July 21st, 2015

Use of Extrusion-Enabled Pharmaceutical Processes in Drug Development via a Streamlined Regulatory Pathway

July 20th, 2015

Final Rule—Drug Shortage Regulation: Incentive for Development of “Unapproved” Drugs?

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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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