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GMP Inspection Preparation Checklist: A Tool for Internal Auditing

This management report includes more than 650 items organized in three sections covering all aspects of quality manufacturing.
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Biological Risk Evaluation and Management for Medical Devices

Report shows how the FDA incorporates the two ISO standards in its medical device development policy, how the EU version of the two standards differs in significant ways and how the EU Medical Device Regulation may require further changes in the European standards.

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Oct 18

Retooling Risk-Based Quality Management Approaches in the Era of ICH E6(R2)

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The CDER Reorganization: What It Means for Drugmakers

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13th Annual FDA Inspections Summit

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FDA Data Integrity: For Device and Pharma Firms, and Their Suppliers

Oct 30

Understanding ISO 19011:2018: The Path to Better Medical Device System Audits

Nov 1

SOPs and Policies for the 21st Century: Why Less is More

Editor's Picks

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MHRA Recalls Digital Pregnancy Tests

The recall affected one lot involving 58,000 tests distributed in the UK. 
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Miami Pharmacy Owner Admits to Submitting Over $8 Million in Fraudulent Medicare Claims

The plea followed an investigation by the Justice Department’s Medicare Fraud Strike Force.
FDAnews Drug Daily Bulletin

FDA APPROVES VALEANT'S CESAMET

May 25, 2006
KEYWORDS FDAnews Drug Daily Bulletin
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The FDA has given marketing approval for Valeant Pharmaceuticals' Cesamet oral tablets to treat nausea and vomiting in patients undergoing chemotherapy.

Cesamet (CII) (nabilone), which Valeant purchased from Eli Lilly in 2004, is a synthetic cannabinoid that interacts with the part of the nervous system that regulates nausea and vomiting. It has a long-lasting effect and can be taken less frequently than many other treatments.

Valeant currently sells Cesamet in Canada where it has an 86 percent share of the cannabinoid market. The company said it intends to launch the drug in the U.S. in the next several weeks.