Have A Question?

Connect with Camargo today.

Contact Us
Blog & Resources Camargo Blog 505(b)(2) Development

The Camargo Blog

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

March 30th, 2015

Priority Review Vouchers are a Big Carrot for Hungry Companies

March 29th, 2015

PhRMA and GPhA Team Up (!) to Offer their EAR Proposal to Solve Generic Safety Labeling Issue

March 24th, 2015

Opportunities in Orphan Drug Development for Investors, Pharma and CROs

February 27th, 2015

MAPPing Out the Timing of a Complete Response Submission

February 25th, 2015

Extending Exclusivity: How Long Will It Really Last?

January 17th, 2015

2014 505(b)(2) NDA Approvals

January 17th, 2015

FDA 2014 NDA Approvals—The Surge of the Niche Products—Good or Bad?

December 18th, 2014

The Potential Unveiling or Unraveling of Dormant Therapies—15-Year Data Exclusivity for Drugs for Unmet Needs

December 10th, 2014

Manufacturing Support for “Breakthrough Therapy—Designation for Solid Oral Dosage Forms

December 10th, 2014

Therapeutic Equivalence Ratings Under 505(b)(2)

November 24th, 2014

Orphan Drug Exclusivity for a Previously Approved Drug: a 505(b)(2) Conundrum

October 28th, 2014

5-Year Exclusivity for Certain Fixed-Combination Drugs with an NCE

September 26th, 2014

Alkermes Prodrug for Treatment of Multiple Sclerosis: NCE?

September 22nd, 2014

Paper Submissions: Going, Going… Away

July 22nd, 2014

MannKind Breathes Easier—Inhaled Insulin Finally Approved

April 8th, 2014

The Road to Commercial Success—The Target Product Profile

February 23rd, 2014

Top Generic CEO’s Confirm Importance of 505(b)(2) in Their Company’s Financial Future

January 19th, 2014

2013 505(b)(2) NDA Approvals

January 13th, 2014

Expensive, Cheap, Value? CMO costs.

September 29th, 2013

505(b)(2) Can Reference Any Scientifically Reliable Evidence—FDA’s Dr. Woodcock

July 30th, 2013

ANDA but No NDA—What to Rely On?

July 26th, 2013

PREA—Pediatric Plan Timing Changed by PDUFA V

July 1st, 2013

FDA Goes Against Advisory Committee and Approves Low Dose Paroxentine for Hot Flashes

May 28th, 2013

505(b)(2) Prodrug Fails Phase III Study

Page 3 of 12

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

9825 Kenwood Road,
Suite 203
Cincinnati, OH 45242
Durham Office
2505 Meridian Parkway,
Suite 150
Durham, NC 27713
Phone 513.561.3329
Toll Free 888.451.5708
Subscribe for our Latest Insights" class="mr-3 social-icon" style="height: 1.75rem; width: 1.75rem;">