The U.S. Food and Drug Administration, in partnership with international regulatory and law enforcement agencies, recently took action against more than 9,600 websites that illegally sell potentially dangerous, unapproved prescription medicines to consumers. These actions include the issuance of regulatory warnings, seizure of offending websites and $41,104,386 worth of illegal medicines worldwide. Dubbed “Operation Pangea [...]
Posted on 20. Aug, 2015 by Rob Sims.
It’s really helpful for UL to talk to a wide range of QA executives about their software technology goals. Many QA managers tell us that they have to start with the Quality Management System (QMS), which certainly makes sense. QMS applications enable the QA team to record and track quality issues in the manufacturing and [...]
Posted on 17. Aug, 2015 by Karl Kapp.
Next time you want to relieve that minor ache or pain after your marathon or half-marathon or even from just sleeping on your arm in a strange way, think twice. The FDA recently strengthened an existing warning. The warning on prescription drug labels and over-the-counter (OTC) Drug Facts labels is designed to indicate that nonsteroidal [...]
Often, it can be difficult to try to wade through all the new information and guidance being issued by the Food and Drug Administration (FDA). It seems like there is a constant (and never ending) stream of new guidance and draft documents. Fortunately, there is a simple way to find what you are looking for. [...]
Posted on 03. Aug, 2015 by Karl Kapp.
Summer time is filled with fun and sun but, increasingly, it also seems to be filled with severe weather phenomenon such as floods, heat waves and power outages. Here are some FDA instructions that may assist interested persons in determining what to do with their biological products in the event of a power failure. You [...]
It seems that every time you turn around, a president of a company or CEO in the Life Sciences industry is being brought up on charges or a consent decree is being issued. Here are two such examples. Recently, the U.S. District Court of the District of New Jersey sentenced the OtisMed Corporation’s (OtisMed) former [...]
Posted on 20. Jul, 2015 by Karl Kapp.
A study by the Tufts Center for the Study of Drug Development broke down the cost to bring a new prescription medicine to market at an estimated $2,558 million. The two factors making up that number are the actual average out-of-pocket cost of $1,395 million as well as the time costs (expected returns that investors [...]
On May 21, 2015, the committee on Energy and Commerce voted 51-0 to advance the 21st Century Cures Act, a bill to help modernize and personalize health care, encourage greater innovation, support research, and streamline the system. Here are some highlights of what the bill is about: Removing barriers to increased research collaboration—Experts agree that [...]
Posted on 06. Jul, 2015 by Karl Kapp.
It is that time of year again; time to head to the beach. And as most people know, a trip to the beach typically ends up with some type of sunburn if you are not careful. Even on cloudy days. In fact, anytime you are outside in the summertime or any time, you need to [...]