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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 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

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 9th, 2016

Use of Clinical Data in a 505(b)(2) New Drug Application to Delay Nonclinical Testing

November 3rd, 2016

Expedited Approval of FDA-Approved Drugs in Australia

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 29th, 2016

Importing Investigational Pharmaceuticals to the U.S.? Changes Are Coming

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 24th, 2016

Improving Drug Development ROI in 2017

August 18th, 2016

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

August 15th, 2016

Orphan Drug Development: Ensuring Best Time to Market

August 9th, 2016

Pitfalls of Changing the Salt of a Listed Drug

August 4th, 2016

Don’t Let Pre-Approval Inspections and the Drug Approval Process Stall Your Application

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

July 13th, 2016

The Prodrug Benefit of Utilizing the 505(b)(2) Pathway

July 7th, 2016

505(b)(2) CMC Basics: Aligning Chemistry, Manufacturing, and Controls with Clinical Trials

July 6th, 2016

Tropical or Rare Pediatric Disease Priority Review Vouchers: Update and Use of the 505(b)(2) Pathway

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 31st, 2016

Back to Basics: 505(b)(2) FAQs Part 2: Clinical and Nonclinical Studies

May 23rd, 2016

Drug Repositioning: Bringing New Life to Shelved Assets and Existing Drugs

May 16th, 2016

Back to Basics: 505(b)(2) FAQs Part 1

May 4th, 2016

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

April 27th, 2016

Statistical Bootstrapping Method to Take the Uncertainty out of Drug Development

April 20th, 2016

Fixed-Combination Drug Products: Are Phase 2 and 3 Studies Really Necessary?

April 14th, 2016

Faster Approval of Combination Drug Products via the 505(b)(2) Pathway

April 6th, 2016

Product Ideation: Identifying Your Optimal Drug Development Candidate

March 23rd, 2016

Pediatric Applicability or Not—This Revised Guidance is for You

Page 3 of 10

Camargo Pharmaceutical Services provides comprehensive drug development solutions, specializing in customized programs including the 505(b)(2) pathway.

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