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The Camargo Blog

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March 21st, 2016

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

March 14th, 2016

Additional 505(b)(2) Benefits: Selective Safety Data Collection

March 7th, 2016

How Much Is a First Cycle Review ANDA Approval Worth to You?

February 4th, 2016

2015 505(b)(2) NDA Approvals

January 27th, 2016

3-Year Exclusivity May Not Be Worth as Much as You Think

January 24th, 2016

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

December 15th, 2015

New Nonclinical Guidance for 505(b)(2) Products: No Cause for Alarm

October 7th, 2015

The Winding Path to De-Risking Formulation Changes

September 22nd, 2015

Encounters of the Third Sector

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?

June 14th, 2015

Active Ingredients vs. Active Moieties—Perplexity of Understanding the Relationship or Distinction

June 11th, 2015

To List or Not to List—That is the Question

June 2nd, 2015

Pediatrics—What are the appropriate age ranges?

April 7th, 2015

The 505(b)(2) Approval Pathway Provides Opportunities for Generics Companies Seeking New Revenue Streams

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

March 11th, 2015

REMS/ETASU and Safe Use in Bioequivalence Trials

February 27th, 2015

MAPPing Out the Timing of a Complete Response Submission

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

June 30th, 2014

Importing Pre-Launch Products with a Bit of PLAIR

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

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

May 9th, 2013

Don’t Conduct Unneeded Tox Studies

May 7th, 2013

Merck Uses 505(b)(2) for New Combo

May 5th, 2013

Raptor’s Procysbi Costs More Than A Generic (!)

Page 4 of 10

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

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