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The Camargo Blog

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


November 16th, 2009

FDA Approves Xanodyne’s Tranexamic Acid

November 4th, 2009

A New Paradigm for the Development of Drugs for Type 2 Diabetes

November 4th, 2009

Does Europe Have a Pathway for Approval of Drugs Analogous to the FDA’s 505(b)2 Pathway?

November 4th, 2009

GTx Needs a 2nd Phase III Trial and More Safety Data

November 3rd, 2009

FDA Refuse to File: Merck Zetia & Pfizer Lipitor

November 2nd, 2009

FDA Warns P&G Over Use of Drug + Vitamin C

October 30th, 2009

Reference Listed Drugs (RLDs): Can More Than One Be Used?

October 29th, 2009

REMS or RiskMAP or What?

October 28th, 2009

505(b)(2) Submissions: No RLD

October 26th, 2009

Preemption: New Hampshire 1, Sanity 0

October 20th, 2009

505(b)(2) for Formulation Changes

October 14th, 2009

Codeine Sulfate: FDA Continues Drive to Remove Unapproved Products, With a Twist

October 8th, 2009

Allergan Sues FDA to Allow Off-Label Promotion

September 30th, 2009

Biosimilars—An introduction

September 14th, 2009

A Treatment IND is NOT the Same as an IND

September 10th, 2009

Comparability Protocols

September 8th, 2009

DESI Presentation: Q&A

September 1st, 2009

Test Specifications for Stability Studies

August 24th, 2009

FDA Halts Marketing of Topical Ibuprofen Products

August 7th, 2009

FDA Requests Melamine Testing of Ingredients

July 31st, 2009

Colchicine Tablets Approved

July 29th, 2009

Scorecard of FDA Approvals Added

July 28th, 2009

BDSI’s Buccal Fentanyl 505(b)(2) NDA Approved

July 9th, 2009

Benzyl Alcohol—NME Approved Under 505(b)(2)

June 29th, 2009

Make the Most of Your Interactions With the FDA: FDA Meeting Requests

June 26th, 2009

Linking Preclinical (Safety), Clinical (Efficacy) and CMC (Quality) Development Activities

June 12th, 2009

ANDA Suitability Petition vs 505(b)(2)

June 9th, 2009

Electronic Filing of eCTD INDs

June 8th, 2009

Writing and Submitting Electronic 505(b)(2) INDs

June 4th, 2009

Melphalan—New 505(b)(2) Orphan Designation

June 4th, 2009

Risk Evaluation Mitigation Strategy (REMS) for Long-Acting Opioids

June 2nd, 2009

Cheerios®: Breakfast Cereal or Drug?

June 1st, 2009

What are DESI Drugs?

May 29th, 2009

MAP Pharmaceuticals 505(b)(2) Dihydroergotamine Orally Inhaled Product Meets Phase 3 Goals

May 15th, 2009

505(b)(2) IV Acetaminophen

May 15th, 2009

Quick-release Bromocriptine Mesylate Approved

May 11th, 2009

Multiple Dosage Strength Products—CMC Considerations

May 8th, 2009

505(b)(2) Combination Products

May 4th, 2009

Polypill: a 505(b)(2) Candidate

April 17th, 2009

505(b)(2) Program: BTG’s Paxclitaxel Gel for Oesophageal Cancer

April 13th, 2009

505(b)(2) Head Lice Treatment Approved

April 13th, 2009

Morphine Solution—FDA Changes Its Decision

Page 7 of 9


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


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