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The Camargo Blog

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

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 4th, 2008

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

May 2nd, 2008

505(b)(2) RLD Patent Certification

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

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

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 7th, 2007

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

December 1st, 2007

505(b)(2)—Part 2: The Assessment: Pharmacokinetic Review

November 16th, 2007

505(b)(2) Combo Plavix/Prilosec

November 12th, 2007

505(b)(2)—Part 2: The Assessment: Preclinical Review/Preclinical Plan

November 8th, 2007

505(b)(2)—Part 2: The Assessment: Safety Review

November 8th, 2007

P&G Drops Out of a 505(b)(2) Development

November 5th, 2007

505(b)(2)—Part 2: The Assessment: Competitive Product(s) Review

November 5th, 2007

Foreign Inspections by FDA

November 1st, 2007

505(b)(2)—Part 2: The Assessment: Overview

October 30th, 2007

505(b)(2)—Part 1: The Overall Process

October 28th, 2007

505(b)(2)—Freedom from Generic Competition—Exclusivity Issues

October 16th, 2007

Drug Repositioning: 2 Flavors

October 8th, 2007

First Generic FDA Review Time to Drop

September 28th, 2007

FDA Moving Against Unapproved Hydrocodone Products

September 27th, 2007

CNN Story on “Unapproved Drugs”

September 21st, 2007

PDUFA 2007—New Submisson Fees for 505(b)(2) Applications

September 14th, 2007

505(b)(2) of Withdrawn Product

September 14th, 2007

Inactive Ingredients Exposed

September 14th, 2007

Use CMO’s Labs or Outside Labs

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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