Author Archives: Mark Senak

Weekly Roundup 1.12.18

As we ease into the new year cycle, 2018 is still waking up. Many of FDA’s web pages are not yet updated to reflect that the new year even exists. The weather is erratic, with low low temperatures one day … Continue reading

Posted in Weekly Roundup | Leave a comment

Advisory Committee Activity for 2017

Having worked with a lot of companies to prepare for an FDA Advisory Committee (AdComm) , I track the activities of the committees in a database marking outcomes, votes and other characteristics. As part of a look-back series as we … Continue reading

Posted in Advisory Committee Prepapartion | 2 Comments

Weekly Roundup 1.5.18

Welcome to the first Weekly Roundup of the year! The fact that it was a short week and one in which the East Coast and a good deal of the South were experiencing a weather challenge means that there was … Continue reading

Posted in Weekly Roundup | Comments Off on Weekly Roundup 1.5.18

Biggest FDA Developments for 2017

As we begin the new year, it is time toassess the previous year and consider what really mattered when all is said and done. We’ve perhaps already done this on a personal level, but here is my take on an … Continue reading

Posted in FDA Image, FDA Policy | 1 Comment

Weekly Roundup 12.15.17

This is it folks, the final stretch. Winter will arrive next week. Travel plans are underway. The last of the gifts are being bought and prepped for the big wrap. And speaking of wrapping up, there are a number of … Continue reading

Posted in Weekly Roundup | Comments Off on Weekly Roundup 12.15.17