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The Camargo Blog

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


December 13th, 2010

Use of Pharmacokinetic n(PK) Modeling & Steady-State Simulations in 505(b)(2) Drug Development

December 11th, 2010

Nuedexta®—Smart Pharmacology to Treat a Unique Disorder

November 22nd, 2010

Endpoint for GI Toxicity Clarified

October 18th, 2010

Company Officials Personally Liable

October 15th, 2010

When is an IND Required?

October 6th, 2010

505(b)(2)s with Minimal Sponsor Studies

October 5th, 2010

Why have a Quality Overall Summary for the Quality Module?

September 27th, 2010

FDA Places Hold on All ANDA PAS & CBE Reviews

August 31st, 2010

Failed 505(b)(2)?: Vivus™ Qnexa

August 23rd, 2010

Lannett’s Morphine Sulfate Oral Solution: 505(b)(2) or 505j?

August 23rd, 2010

Will We Have Generic User Fees? Public Meeting to Be Held.

August 20th, 2010

Generic Lovenox: 505j or 505(b)(2)

August 4th, 2010

New User Fees for 2011

August 1st, 2010

Still Submitting Paper ANDA Applications?

July 15th, 2010

Avandia: Who Won?

July 12th, 2010

Advisory Committee Meeting: Rosiglitazone

June 29th, 2010

The Skinny On a Potential New Treatment of Obesity

June 10th, 2010

Labeling for Abuse-Deterrent Drugs

May 19th, 2010

Prodrug Denied

May 14th, 2010

Target Product Profile

April 30th, 2010

CMC Issues Again

April 23rd, 2010

Manufacturing Problems for Intravenous Emulsions

April 23rd, 2010

Oxycodone + Niacin Voted Down 19-1

April 21st, 2010

FDA Advisory Committee to Review Acura’s Oxycodone Plus Niacin; Risk/Benefit in Question

April 20th, 2010

505(b)(2): Repositioning, Repurposing or What?

April 19th, 2010

Biosimilars or Biodissimilars?

March 26th, 2010

505(b)(2) Approvals

March 18th, 2010

FDA Removes Unapproved Nitroglycerin Tablets

March 12th, 2010

FDA’s Determination of Vyvanse as NME Upheld

March 10th, 2010

FDA’s DAARP is now DAAP, DPAP is now DPARP

March 3rd, 2010

Exalgo Approved

March 2nd, 2010

Do Not Neglect Your Third-Party Drug Substance Manufacturer

March 2nd, 2010

Proposed FDA Rule Would Make Sponsors More Responsible for Data Integrity: Way More Responsible

February 23rd, 2010

Spending on DTC Advertisements

February 20th, 2010

Generic Approvals Taking Longer

February 11th, 2010

Can and Should ANDA Labeling Differ from the RLD?

February 11th, 2010

Roche’s Actemra Approved for RA After Year’s Delay

February 8th, 2010

News on the Biosimilar Front

February 5th, 2010

Pediatric Assessments in Drug Development: Timing in Europe vs. US

February 4th, 2010

Once Daily Trazodone Approved

February 3rd, 2010

It’s Budget Time at the FDA!

January 27th, 2010

Morphine Sulfate Oral Solution-Roxane is First Across the 505(b)(2) Finish Line

Page 6 of 10


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


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