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By Lori Clapper, Web Editor

FDA Realigns, Strengthens New Drug Approval And Evaluation Capabilities
As a result of new regulatory responsibilities and evolving drug development activity in certain therapeutic areas, the FDA has decided to realign its Center for Drug Evaluation and Research's (CDER) Office of New Drugs (OND), effective March 15, 2010.

CDER's Office of New Drugs is known as a "super office," under which there are currently six Offices of Drug Evaluation (ODEs). Each of these offices has several divisions, whose staff members are responsible for reviewing and evaluating investigational new drug applications (INDs), new drug applications (NDAs), and biologics license applications (BLAs) for drug and biologic products intended to diagnose or treat specific diseases and conditions. The agency has also realigned various review functions to enhance the logical groupings of applications within each ODE and division, and to achieve a more balanced workload across OND review divisions.

Read more about the realignment here.

FDA Issues Warning To Paddock Laboratories
On March 1, the FDA issued a warning letter to Paddock Laboratories concerning the marketing of the drug Morphine Sulfate Concentrate Oral Solution 20 mg/ml. According to the letter, the FDA does not have an approved application on file for the drug and its label does not contain adequate directions for use.

The letter states that because the "product is intended for conditions that are not amenable to self-diagnosis and treatment by individuals who are not medical practitioners, adequate directions cannot be written for it so that a layman can use this product safely for its intended uses."

Read the letter here.

Avoiding Medication Mix-Ups
The FDA hopes a name change for another drug will mean fewer medication errors. The agency OK'd a name change for Takeda Pharmaceuticals' heartburn drug Kapidex (dexlansoprazole), which will be marketed under the new name Dexilant beginning this April.

Since Kapidex was approved last January, there have been reports of dispensing errors with Casodex (bicalutamide) and Kadian (morphine sulfate) — which have very different uses.

"The FDA is pleased to have worked with Takeda to take swift and responsible steps to change the name of this product in the interest of patient safety," said Janet Woodcock, M.D., director of the FDA's Center for Drug Evaluation and Research.

To improve this safety process, the FDA has issued a new guidance for industry titled Contents of a Complete Submission for the Evaluation of Proprietary Names. The guidance explains what information should be submitted to help in the evaluation of a proposed proprietary drug or biologic name, and to ensure compliance with other requirements for labeling and promotion.

Advisory Committee Meeting
The Pharmaceutical Science and Clinical Pharmacology Advisory Committee will meet March 17 in Atlanta. The agenda includes general scientific issues related to pharmacogenomics in drug development, as well as recent developments in transporter-mediated drug interactions. Click here for more information and updates.

The committee's next meeting will be held on April 14, in Silver Springs, MD.