FDA News Update
FDA New Tobacco
FDA new tobacco regulation also known as the Deeming Regulation takes effect in 30-days (August 8, 2016). The regulations are broad, complex and impact every…
Tobacco Products Required Warnings
Among the key requirements of the FDA’s new Deeming Tobacco rule are that tobacco products bear the required warnings. This rule states advertising and packaging warnings…
FDA Enforcement and Recall Report Week of May 31
Each week the FDA reports on its enforcement activities. To help capture and digest that information the FDA Atty blog will post FDA recalls and…
FDA Enforcement and Recall Report Week of May 23
FDA Enforcement Report **This week’s FDA enforcement report is tardy due to meetings on FDA’s White Oak campus (read a post on the visit here.)**…
FDA Device Meetings
FDA Device Meetings Any meeting with the FDA on it’s White Oak campus can be intimidating, but a FDA device meeting to assess both pre-market…
FDA Enforcement and Recall Report Week of May 16
Each week the FDA reports on its enforcement activities. To help capture and digest that information the FDA Atty blog will post FDA recalls and…
FDA Comments Deeming Regulation
FDA Comments Deeming Regulation This afternoon I attended a meeting with CTP Director Mitch Zeller regarding the deeming regulation (“FDA Comments on Deeming Regulation”). CTP Director…