Resources

The question of FDA regulation of medical device applications, also known as “apps”, intended for use on mobile devices such as smart phones and tablets is an open-ended one that MDCI has tackled in previous blog posts. A new frontier for medical device apps appears to have opened up, with the announcement by Ford that […]

The FDA is having a very busy year.  Q1 saw a slew of approvals, policy changes, high-profile stories, enforcement activities, and personnel changes.  Q2 was no different.  Here are our top 30 stories on the FDA for Q2 of 2011. The Big Stories of the Quarter The Drug Shortage:  Some people say the FDA is […]

The answer depends on who you listen to: the FDA or the EVP at CSL Biotherapies. According to the FDA Warning Letter issued on June 15, 2011, the issues are among the most significant as any we have seen in recent years following the company withdrawal of the vaccine after reports of seizures with use in […]

Years ago, while helping an incoming administration evaluate the public health service agencies at HHS, I became captivated by the idea that a series of reorganizations would solve many of the problems. I eventually snapped out of my trance and learned a life-long lesson: redrawing organizational boxes and altering reporting relationships are rarely effective solutions. […]

This Webinar by a team of seasoned GXP validation and SharePoint experts will introduce innovative best practice risk-based strategies, important processes and new exciting tools to help qualify enterprise Microsoft SharePoint deployments as well as validate mission critical applications such as clinical and investigator portals and document management in FDA regulated environments. The presentation — […]

Join us and learn from former FDA Chief Counsel Sheldon Bradshaw about FDA’s greater enforcement efforts and warning letter changes: setting post inspection deadlines, speeding up warning letter process, working more closely with regulatory partners, implementing warning letter close out process, and much more. Set Post-Inspection DeadlinesSpeed Up Warning Letter ProcessWork More Closely with Regulatory […]

Did you know that you must use FDA-defined terms where they exist – it’s best for you consider them “sacred.” In his 8th appearance in this highly praised webinar, discover a potential table of contents for your quality agreement, why you must use FDA defined terms where they exist. Learn the obligations for all stakeholders […]

The FDA’s approach to enforcing product safety and efficacy is evolving when it comes to CMOs and CROs. FDA is increasingly holding both sponsors and contract organizations responsible for a product’s safety and effectiveness. Whether in clinical trials or in the post-market stage, patient safety is the #1 driver for FDA enforcement. So how do […]

One of our most praised presentations, this Webinar by renowned eCTD expert Antoinette Azevedo will provide an overview of best practices to enable a sponsor to prepare a compliant eCTD for regulatory authority review. So you can avoid a costly Refuse-to-File (RTF) by FDA. Negotiations are underway between FDA and industry on PDUFA V reauthorization. […]

Did you know that 5 of the top 7 FDA risk enforcement priorities involve your senior management team? Learn how your senior management team can management FDA compliance effectively with just 48 hours per year. Discover 14 typical FDA auditor questions regarding quality systems management, top 7 FDA risk enforcement priorities. Learn six do’s and […]