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CTP Reports Progress on Reagan-Udall Review - Tobacco Reporter Online
Brian King, director of U.S. Food and Drug Administration’s Center for Tobacco Products (CTP), published a statement summarizing the CTP’s progress in addressing the recommendations from the Reagan-Udall evaluation.
CTP’s Progress Addressing Recommendations from the Reagan-Udall Evaluation -Statement from CTP Director-
In February, I announced the Center for Tobacco Product’s (CTP) “all-center” approach to responding to the evaluation of our center by an independent expert panel facilitated by the Reagan-Udall Foundation (RUF), including our plans to address the 15 recommendations outlined in the evaluation panel’s report.
FDA rethinks reorganization, allocates more authority to proposed deputy commissioner for human foods - Food Navigator
Heeding the advice of food industry leaders and public safety advocates, FDA has “significantly broadened” the proposed responsibilities and oversight of the planned Human Foods Program under a larger reorganization that seeks to address shortcomings revealed in two high-profile reviews of the agency.
ChatGPT Poses New Regulatory Questions for FDA, Medical Industry Bloomberg Law
Large language models popularized by ChatGPT show up in nearly all of FDA Commissioner Robert Califf’s speeches lately, as he makes clear he wants to get ahead of regulating the disruptive technology.
House committee directs FDA Commissioner to unify FDA food programs with a clear chain of command - Food Safety News
An appropriations bill from a committee in the U.S. House of Representatives would direct the FDA to unify its food program under one person.
The move echoes the sentiment from a House committee, former FDA leaders, and experts in the field of food safety.
Staking a Claim? - The Tobacco Reporter
It seemed an excellent test case for a new system. After role-playing a U.S. Food and Drug Administration Tobacco Products Scientific Advisory Committee (TPSAC) member, listening to Altria’s presenters rehearse their pitch, that was my impression.
Supplemental Filings: Califf Discusses Revolving Door; Poll Examines Public Trust In FDA Approvals - Pink Sheet
Commissioner Robert Califf continues to raise attention about what he terms the “revolving door for lawyers,” between the FDA and industry.
Agency staff leaving for jobs in the private sector is nothing new, but Califf mentioned during a speech at the Food and Drug Law Institute’s Annual Conference that the attention seems directed at departing scientists, rather than attorneys.
FDA Commissioner Laments Lawsuits - Tobacco Reporter
U.S. Food and Drug Administration Commissioner Robert Califf has lamented the FDA’s ongoing tobacco industry litigation following the agency’s attempt to regulate e-cigarettes, according to Politico. The FDA is facing over 40 lawsuits from companies whose premarket tobacco product applications have been denied.
Califf Plans US FDA, NIH Collaboration On Postmarket Evidence Generation - Pink Sheet
US Food and Drug Administration Commissioner Robert Califf’s evidence generation enhancement plans will include the National Institutes of Health, assuming that agency’s new leader takes office.