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The Camargo Blog

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


August 22nd, 2008

Modeling Using Dissolution Data

August 7th, 2008

Residual Solvents—New FDA Draft Guidance

August 4th, 2008

$1,247,200 PDUFA Fees for FY 2009

July 20th, 2008

Current versus RLD Approval Requirements

July 15th, 2008

PREA and 505(b)(2)

July 3rd, 2008

Hospira Expands Into 505(b)(2) Development

July 2nd, 2008

505(b)(2)—No Patent, Just Exclusivity

July 2nd, 2008

BIO—User’s Manual

June 15th, 2008

Creating a Safer NSAID

June 10th, 2008

Raptor Announces Orphan Designation for Cysteamine Bitartate

June 7th, 2008

Indevus’ Stock Drops 70% on FDA’s Request for More Safety Data

June 4th, 2008

Fenofibrate in the News (Again)

June 1st, 2008

What’s the Competition?

May 27th, 2008

Multiple RLD’s Under 505(b)(2)

May 26th, 2008

RLD—Born in the USA

May 18th, 2008

Paragraph IV Certifications Under 505(b)(2)

May 14th, 2008

Biovail to Reduce 505(b)(2) Development

May 14th, 2008

Fospropofol Turned Down or Approved by FDA Advisory Committee?

May 11th, 2008

505(b)(2) Orphan Drug Approval With Only a BE Study?

May 4th, 2008

Racemate > Isomer Approval Under 505(b)(2)

May 2nd, 2008

505(b)(2) RLD Patent Certification

May 2nd, 2008

505(b)(2) With Orphan Indication

May 2nd, 2008

Trade Secrets

April 23rd, 2008

505(b)(2) Patent & Marketing Exclusivity

April 16th, 2008

NanoNews—Beads Deliver Drug to Site of Action

April 15th, 2008

505(b)(2) Pre-IND Meetings Denied

April 15th, 2008

Is Your Drug Project a 505(b)(2), ANDA or OTC?

April 3rd, 2008

505(b)(2) Patent & Exclusivity

March 28th, 2008

Approval Delays at FDA

February 15th, 2008

Metabolites: New Safety Testing Requirements—Impact on 505(b)(2)

February 7th, 2008

A Single Phase 3 Trial Needed for 505(b)(2) Approval of a Combination Drug

February 7th, 2008

Another “Unapproved” Drug Needs a 505(b)(2) Approval

January 30th, 2008

505(b)(2—Part 3: Pre-IND Submission & Meeting

January 17th, 2008

505(b)(2) with Only Phase 1 Study

January 16th, 2008

505(b)(2)—Part 2: The Assessment: Timeline, Cash Flows

January 10th, 2008

FDA Takes Action Against Compounding Pharmacies’ Estriol-Containing Hormone Products

January 10th, 2008

PDUFA 2008—New Submisison Fees for 505(b)(2) Applications

December 24th, 2007

New Safety Reporting Requirements for Unapproved OTC Products

December 19th, 2007

505(b)(2)—Part 2: The Assessment: CMC Development Plan

December 12th, 2007

505(b)(2)—Part 2: The Assessment: Clinical Marketing Assessment

December 10th, 2007

505(b)(2)—Part 2: The Assessment: Clinical Development Plan

December 10th, 2007

505(b)(2)—Part 2: The Assessment: Regulatory Strategy

Page 9 of 10


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


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