Fighting Counterfeit Drugs – FDA Draft Guidance

Counterfeiting is a growing global problem.  The infiltration of counterfeit drugs into mainstream supply chain in many countries poses a direct threat to consumer health, worldwide.  The U.S. is no exception.   Counterfeit products fall under the classification of intellectual property rights (IPR) violations.  The U.S. Customs and Border Protection, reports that the domestic value of [...]

3 Things You Should Know About Product Recalls

  News about tainted and recalled products appear to be more frequent recently.  While most of us are aware that the intent of product recall is public safety, few of us know what the process entails.  Here are three things to fill the knowledge gap.  1.    What is Product Recall?  A product recall is essentially [...]

A Profile of the FDA – what it is and what it regulates

  The Agency  The Food and Drug Administration (FDA) is a federal agency within the Department of Health and Human Services (DHHS).  It is responsible for protecting the U.S. public by ensuring the safety, efficacy, and security of human and veterinary drugs, biological products, medical devices, the food supply (except for meat, poultry, and some [...]

FDA Enforcement Report – July 22, 2009

The FDA publishes a weekly Enforcement Report, which details product recall and field correction activity of the agency.  It is a vital resource for both industry and consumers. Each report provides information about  recalled products, including:   product name and code manufacturer volume of product in circulation geographical distribution of product reason for the recall Not surprisingly, [...]