Medical Device Development Tools (MDDT) Program

Posted on 21. Sep, 2015 by .

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, [...]

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Impact of Continuous GMP Training on Company Culture

Posted on 18. Sep, 2015 by .

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 [...]

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The Inherent Result of an Obvious Process

Posted on 14. Sep, 2015 by .

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 [...]

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Off-Label Rulings and the First Amendment Impacting What You Can Say About Products

Posted on 08. Sep, 2015 by .

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 [...]

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Draft Guidance Issued for “Unexpected Adverse Event” Reporting for Outsourcing Facilities

Posted on 31. Aug, 2015 by .

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. [...]

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Cracking Down on Illegal Websites

Posted on 24. Aug, 2015 by .

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 [...]

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When to Move from the QMS Training Module to the LMS

Posted on 20. Aug, 2015 by .

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 [...]

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FDA Strengthens Warning of Heart Attack and Stroke Risk for Non-Steroidal Anti-Inflammatory Drugs

Posted on 17. Aug, 2015 by .

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 [...]

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