Regulatory Affairs Syndicator

Arranon was approved under FDA’s accelerated approval program, which allows FDA to approve products for cancer and other serious or life-threatening diseases based on early evidence of a product’s effectiveness.

Topics: Implantable Cardioverter Defibrillator

The U.S. Food and Drug Administration (FDA) announced revised implementation dates for a strengthened distribution program for isotretinoin, called iPLEDGE, aimed at preventing use of the drug during pregnancy.

This is to provide new information about a possible association between the Vapotherm® 2000i Respiratory Gas Administration device, which is used to add moisture and warm breathing gases through a nasal canula in patients receiving supplemental oxygen…

The meters can unintentionally be switched from one unit of measurement to another, resulting in an inaccurate blood glucose interpretation by the user.

The tissue was recovered by BTS from human donors who may not have met FDA donor eligibility requirements and who may not have been properly screened for certain infectious diseases.

FDA is notifying health care providers and patients of a problem with blood glucose meters made by Abbott Diabetes Care, Alameda, Calif. The meters can unintentionally be switched from one unit of measurement to another, resulting in an inaccurate…..

Topics: Dental, Dental Composites

This document was developed as a special control to support the classification of CFTR (cystic fibrosis transmembrane conductance regulator) gene mutation detection systems into class II (special controls).

In response to the emerging threat of pandemic (Avian) influenza, the Food and Drug Administration (FDA) has announced the formation of a Rapid Response Team to ensure that antiviral drugs are available to the American people, in the event they are needed.

• List of Firms Receiving Warning Letters
• Sample Warning Letter October 17, 2005