Tissue-engineered and regenerative medicine products are promising innovative therapies that can address unmet clinical needs. These products are often combinations of cells, scaffolds, and other factors and are complex in both structure and function. Their complexity introduces challenges for product developers to establish novel manufacturing and characterization techniques to ensure that the...

BACKGROUND The United States (U.S.) Food and Drug Administration, as protectors of public health, encourages generic drug development and use so that patients can access affordable medications. The FDA, however, has limited mechanisms to encourage generic drug manufacturing. MAIN RESULTS Generic drug manufacturers make decisions regarding development of products based on expected profitabilit...

The Food and Drug Administration (FDA) approves drugs for sale in the United States based on its determination that the clinical benefits of a drug outweigh its potential health risks. To make this decision, FDA reviews supporting data collected from several thousand patients during the drug’s development. Once a drug is approved for marketing and used by potentially hundreds of thousands of pa...

Orphan drugs or drugs for rare diseases represents a particular regulatory conundrum. There is a desperate need for effective therapies for these patients, who have been historically underserved by the drug development community. However, there is also a need to make sure these therapies are both safe and effective. In response, the US Food and Drug Administration (FDA) has evolved new approach...

Two years ago, more than 300 people gathered outside Washington, D.C. to tackle one of the most pressing challenges in healthcare— making infusion devices and systems safer. What’s changed? The AAMI/FDA Infusion Device Summit in October of 2010 has proven to be a catalyst for healthcare professionals who care about one of the most important safety issues of our time— infusing patients safely. T...

In 2010, in response to a prolonged debate over the safety of long-acting beta-agonists (LABAs), the United States Food and Drugs Administration (FDA) issued guidelines for the use of LABAs in asthma, and mandated a very large trial examining the safety of LABAs used with concomitant inhaled corticosteroid (ICS). Strong voices have called for new safety data, 4 while others have expressed doubt...

What is Fuzz Testing? Fuzz testing is a type of negative software testing. In contrast to positive software testing, during which one tests whether the software is behaving as it should, negative testing seeks to check whether the software doesn’t behave the way it’s not supposed to. Fuzz testing typically applies test vectors that are almost correct, such as an invalid packet-length field in a...

The Food and Drug Administration (FDA) is amending its combination product regulations to define "mode of action'' (MOA) and "primary mode of action" (PMOA). Along with these definitions, the final rule sets forth an algorithm the agency will use to assign combination products to an agency component for regulatory oversight when the agency cannot determine with reasonable certainty which mode o...