Blog @ ComplianceZen.com

FDA Training Records – 3 Risky Challenges

Companies train their personnel in all sorts of FDA-related activities, from quality system SOPs to core regulatory requirements to company policies. Training is a common requirement of nearly all FDA regulations  … Continue reading at ComplianceZen.com →

Should FDA Regulate Medical Apps?

This week, Congress is holding hearings on FDA’s plan to oversee and regulate medical apps for smartphones as medical devices. As I wrote back in my Medical Apps, FDA and Patient Data Integrity posting, the regulation of medical apps is  … Continue reading →

3D Printing and Nanobots – FDA Challenges

FDA regulates medical devices such as stents and prosthetics. FDA regulations – and compliance – are predicated on an assumption that medical device production is an involved undertaking that requires expertise, monies, and physical manufacturing.  Yet, what would happen – … Continue reading →

From the Pharma Contracting & Outsourcing Conference

This past week I was invited to speak at the Contract Pharma Contracting and Outsourcing Conference in New Jersey, where I spoke on how to sell compliance to senior management.  All too often we assume that compliance is an essential … Continue reading →

Medical Apps and FDA Regulation

Two recent articles – one in the Washington Post and one in the Wall Street Journal – have raised the spectre of how smartphone medical apps imply an imminent trainwreck between today’s rapid-pace innovation and last century’s slower-going FDA regulation … Continue reading →

From the IMDA Medtech Conference

New European medical device regulations are due within 18 months. The new rules will update the current Medical Device Directives (MDDs) for the 21st century, and close the gaps so brutally uncovered by the PIP scandal and … Continue reading … Continue reading →

Lowering Liability Risks with Supplier Qualification

Earlier this year, I spoke with medical product liability expert and lawyer, Sara Dyson,  on ways to reduce drug and device product liability risks through effective supplier due diligence and qualification … Continue reading at ComplianceZen.com →

FDA Compliance Training – Free Consulting?

“Which is better – hiring a consultant to come and conduct an onsite workshop for my team or sending folks out to various third-party classes and industry conferences?” Well, to paraphrase the FDA, it depends. There are three typical considerations … Continue reading →

From the NIH – Biotechnology Landscape 2020

Last week I spoke to the NIH biotechnology business leadership in Bethesda, Maryland. To the standing room only crowd, I laid out the challenges that we face over the next decade – the rising cost of new drug development, the … Continue reading →

FDA Forecast for 2012

Expecting something from the FDA is a risky endeavor, and that makes it all the more worthwhile to read the tea leaves every once in a while. The agency will struggle to maintain traction in 2012. Congress began second guessing … Continue reading →