FDA Articles

Pharmaceutical & Medical Packaging News
January 1998

Pharmaceutical & Medical Packaging News
December 1999

Applied Clinical Trials, Dec 1, 2001

Pharmaceutical Representative, May 1, 2003

Sponsors are underwriting more studies of children, but controversy continues over the need for FDA’s pediatric rule and the impact of extended exclusivity o­n generics.

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Barely a month after losing a vital Supreme Court case, the FDA has a new Compliance Policy Guide (CPG) to replace provisions of the Food & Drug Administration Modernization Act (FDAMA) that were struck down by the high court o­n April 30 (see Drug Topics, May 20). At the same time, the FDA is considering new legislation to replace FDAMA compounding provisions. FDA did not consult with pharmacy organizations or open the CPG to advance comment.


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An effective, well-developed, and versatile preapproval inspection model focuses management and inspectors o­n conclusions, minimizes process reinvention, and tracks inspection readiness, especially when you are using a contract manufacturer.


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A Food & Drug Administration advisory panel voted last month to intensify safety precautions for women taking isotretinoin (Accutane, Roche), in the wake of reports that industry tracking efforts have failed to lower rates of dangerous pregnancies in women using the drug. Experts voted to recommend that regulators mandate stepped-up protections, including mandatory education programs and registration of all pharmacists who fill prescriptions for Accutane and its generic equivalents. The recommendations also require pharmacists to phone into a registry to verify patients' negative pregnancy tests before being allowed to fill an order for the drug. Experts voted unanimously to recommend an end to a program run by Accutane maker Hoffmann-La Roche, called the System to Manage Accutane-Related Teratogenicity, or SMART.

Victoria Lander
BioPharm International, February 2004

The FDA has published a compliance policy guide for implementing feasibility studies and pilot programs for radio frequency identification (RFID) technology to deter counterfeiting and diversion. The agency has also created an internal RFID Workgroup to monitor the adoption of RFID technology in the prescription drug supply chain. (For more o­n RFID) Out with the old Wolters Kluwer Health has removed old medical abbreviations from its drug databases in order to comply with a new patient safety goal set by JCAHO. The drug information publisher has upgraded its Medi-Span product offering with a new component, the Supplemental Name file, in order to reduce Rx errors caused by dangerous abbreviations.