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The Camargo Blog

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


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 Pharmaceutials 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

April 1st, 2009

FDA Stops DESI Unapproved Rx Narcotics

March 30th, 2009

Botanicals: What is the Starting Material for the API?

March 23rd, 2009

Generic Cliff

March 23rd, 2009

What to Develop?

March 19th, 2009

One vs. Two Batches for Single-Dose and Multiple-Dose Studies

March 9th, 2009

505(b)(2) Development Risks

February 28th, 2009

Generic Biologics

February 18th, 2009

Use of Data from Foreign Clinical Studies for US Approval

February 5th, 2009

2008 505(b)(2) Approvals

February 2nd, 2009

Dexlansoprazole Approved for the Treatment of GERD

January 29th, 2009

Watson’s 505(b)(2) Overactive Bladder Gel Approved by FDA

January 27th, 2009

New (Draft) Guidance on Standardized Numerical Identification (SNI) for Drug Products

January 15th, 2009

505(b)(2) NDA Labeling

December 23rd, 2008

What is a ‘483?

December 16th, 2008

Fenofibrate (TriCor) Active Metabolite Approved

December 16th, 2008

What is an NME?

December 3rd, 2008

505(b)(2) Combination Meets Phase 3 Goals

December 3rd, 2008

Brand Name Drugs No Better Than Generics

November 25th, 2008

Medicaid Paid for Unapproved DESI Drugs

October 31st, 2008

Sertraline + CBT—a New 505(b)(2) Combo

October 13th, 2008

Drug Repositioning Summit 2008

September 17th, 2008

FDA Bans 30+ Ranbaxy Generic Drugs—Except 1 Sole Source

September 16th, 2008

More DESI-Products Cited. Exceptions are Noted for Unique Products.

September 15th, 2008

505(b)(2) Literature Searches—Too Much or Too Little?

September 2nd, 2008

Shionogi to Buy Sciele Pharma

September 2nd, 2008

Transcept and Novacea to Merge

Page 8 of 10


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


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