Posted on 28. Sep, 2015 by Karl Kapp.
According to a study published in the Journal of American Medical Association, approximately 50% of all Americans have pre-diabetes or diabetes. The goal of the study was to estimate the prevalence and update US trends in total diabetes, diagnosed diabetes, and undiagnosed diabetes using National Health and Nutrition Examination Survey (NHANES) data. The study was [...]
The FDA has a program for the developers of medical devices which can help to qualify tools that medical device sponsors can use in the development and evaluation of medical devices. The program is called the Medical Device Development Tools (MDDT) program. The program provides a qualification which means that according to the FDA website, [...]
Posted on 18. Sep, 2015 by Rob Sims.
I was listening to a radio program recently on meditation, and the speaker made this statement: “You become what you contemplate.” I immediately wanted to use that statement to kick off this blog article, which originally started with the “training statement” found in FDA’s recently published “Request for Quality Metrics” guidance. “FDA has observed that [...]
Takeda Pharmaceutical Company recently lost a ruling related to its product, Velcade. The ruling was in relation to the issuing of a generic version of the product. Takeda Pharmaceutical Company is the largest pharmaceutical company in Japan and Asia and a top 15 pharmaceutical company. The company has over 30,000 employees worldwide and achieved 16.2 [...]
Posted on 08. Sep, 2015 by Karl Kapp.
Another federal court ruling has indicated that the FDA cannot prohibit the truthful promotion of a drug for unapproved uses. The court’s reasoning is because doing so would violate the protection of free speech—it would be a First Amendment violation. Therefore truthful, non-misleading uses of pharmaceutical products may, in the not-too-distant future, become commonplace within [...]
Posted on 31. Aug, 2015 by Karl Kapp.
Recently, the FDA has issued guidance clarifying that any adverse event not included on a compounded drug’s labeling should be considered “unexpected” and reported to the agency. The guidance states: …Section 310.305(b) defines an unexpected adverse drug experience as any adverse drug experience that is not listed in the current labeling for the drug product. [...]
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 [...]