The five-year plan seeks to address the issues of transparency, enforcement, and education. The five goals are: Develop, advance, and communicate comprehensive and impactful tobacco regulations and guidance; Ensure timely, clear, and consistent product application review; Strengthen compliance of ...
2016, and 2017 installments.) The agency’s enforcement for failures in data integrity and data governance began almost 20 years ago. This year, however, we may have turned the corner, which I
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ForFY2020, I see a continuing focus on OTC manufacturers, as there are many of them and they seem to fail to understand the fundamentals of GMPs. The enforcement discretion with stem cell clinics is supposed to cease at the end of the year, but acourt case in Californiacould have...
2018. First of a kind enforcement actions are always of interest in terms of what they tell us about the FDA’s potential future enforcement in this area. Also, the text in the enforcement action provides insight into what the FDA found to be the specific objectionable activity or ...
FDA will exercise enforcement discretion with respect to ingredients that have been reviewed and received a “consultation complete” letter. We note that the interim AFIC consultation program bears some resemblance to the consultations and letters of opinion that were used prior to the implementation ...
potential business risk in that the cost of doing business may be higher than it should be) or too cold (i.e., a potential regulatory risk in that regularity requirements may not be met which, in turn, may result in business risks based on the operational impact of FDA enforcement actions...
The first read of this letter—especially the last sentence on the first page, plus citations—might lead one to believe that FDA is serving-up a new tactic in enforcement, picking on AbbVie for using a public figure for advertising. But FDA’s argument is much more pedestrian—“fast” ...
FDA released online resource page for human and animal food producers who may be affected by flooding, severe weather incidents. It identifies federal and state reso
“that FDA strengthen the mechanisms that are used to ensure that senior leaders share information and coordinate strategic priorities to align criminal enforcement and regulatory activities;” and “that the Agency enhance its debarment and disqualification procedures.” ...