Regulatory Affairs Syndicator

WISH-TV - The Food and Drug Administration says testing has revealed fake versions of Lipitor and other widely used prescription drugs have been sold through web sites linked to a Canadian pharmacy. The FDA says consumers who bought drugs through the 10 web …

The FDA is publishing its annual guidance document agenda. This list is being published under FDA’s good guidance practices (GGPs) regulations. It is intended to seek public comment on possible topics for future guidance document development…

This meeting is a joint meeting of CDRH?s Dental Products Panel and CDER?s Peripheral and Central Nervous System Drugs Advisory Committee to review and discuss peer-reviewed scientific literature on dental amalgam devices.

This story originally aired in October 2005. In this Special Edition of PSN, we are repeating some of the most important safety issues that continue to pose a public health problem.

FDA has issued a public health advisory about deaths and serious…

This story originally aired in February 2006. In this Special Edition of PSN, we are repeating some of the most important safety issues that continue to pose a public health problem.

FDA issued a reminder about the potential for falsely elevated …

This story originally aired in December 2005. In this Special Edition of PSN, we are repeating some of the most important safety issues that continue to pose a public health problem.

FDA and CDC are alerting health care providers and consumers ab…

This story originally aired in December 2005. In this Special Edition of PSN, we are repeating some of the most important safety issues that continue to pose a public health problem.

Luer fittings, connectors, and locks are small, inexpensive, an…

This story originally aired in November 2005. In this Special Edition of PSN, we are repeating some of the most important safety issues that continue to pose a public health problem.

In a recent Medication Safety Alert, ISMP warns about inadverte…

This story originally aired in October 2005. In this Special Edition of PSN, we are repeating some of the most important safety issues that continue to pose a public health problem.

FDA is reminding radiology personnel about the potential for ser…

You’ve heard of people getting prescription drugs from Canadian websites. A new investigation by the FDA says those drugs are fakes.

China will need up to 400 volunteers for the second trial of a bird flu vaccine, after the first phase of clinical trials showed that it is safe for human use.

Peoples Weekly World - Bittersweet. It’s a good word to describe the anticipated U.S. Food and Drug Administration’s recent approval of the controversial contraceptive pill, Plan B. The sweet part is the fact that, after nearly a three-year delay, a decision to allow …

The March of Dimes today urged Food and Drug Administration officials to promptly approve a commercial progesterone therapy that appears to prevent some premature births.Dr. Nancy Green, March of Dimes medical director, testified before the FDA Advisory Committee for Reproductive Health Drugs, which met to discuss “Gestiva,” also known as 17 alpha-hydroxyprogesterone or 17-P. [click link for full

San Jose Business Journal - The effectiveness of Adeza Biomedical Corp. ’s proposed drug designed to prevent preterm labor was questioned Monday by the Food and Drug Administration . Sunnyvale-based Adeza’s (NASDAQ:ADZA) drug, Gestiva, is a long-acting form of a naturally …

Click2Houston.com - The Food and Drug Administration is the agency to contact. Texas’ consumer complaint coordinator will take all of the information and use it to determine if the FDA should initiate a recall. Even if a recall is not issued, the complaint will go into …