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Even over the counter, Narcan may be too costly to reach many drug users - Washington Post
Before month’s end, federal regulators are poised to allow over-the-counter sale of a nasal spray that reverses the potentially lethal effects of an opioid overdose.
But groups that work to reduce the toll of drugs on the streets have one question: Will anybody be able to afford it?
Coalition wants an audience with the Senate committee to discuss FDA leadership - LexBlog
A coalition of consumer and industry groups is seeking a meeting with a Senate committee regarding the head of the FDA and his response to a recent report calling for a reorganization of the agency.
Real-World Evidence Webinar Series: Considerations for the Design and Conduct of Externally Controlled Trials for Drug and Biological Products Draft Guidance for Industry
Real-World Evidence Webinar Series:
Considerations for the Design and Conduct of Externally Controlled Trials for Drug and Biological Products Draft Guidance for Industry
April 13, 2023, 2-3 PM ET
The FDA’s CTP Review Uncovers Multiple Issues - The Vaping Post
It is no secret that the FDA has been under scrutiny for multiple reasons related to the authorization of safer nicotine alternative products. Last Summer the agency was heavily criticised by Senators Dick Durbin (D-Ill.) and Susan Collins (R-Maine).
It’s time for a Department of Food and Nutrition - Food Safety News
The failures of the federal Food and Drug Administration (FDA) have been in plain view since at least early 2022.
At that point the public saw the FDA’s scandalous neglect of Abbott Nutrition’s contaminated infant formula — which was reported to it five months before Abbott recalled the product — and Politico’s detailed exposé of the agency’s incompetence, which extends back through several presidential administrations.
RAISE: Creating Safe Space II: Capturing Race and Ethnicity Data
RAISE: Creating Safe Space II: Capturing Race and Ethnicity Data
Thursday, March 16, 2023
2-3 PM ET
An All-Center Approach: CTP’s Response to the Reagan-Udall Foundation Evaluation Report - FDA Statement
In September 2022, an independent expert panel facilitated by the Reagan-Udall Foundation began an operational evaluation of the Center for Tobacco Products (CTP) at the request of Food and Drug Administration Commissioner, Dr. Robert Califf.
The FDA plan: The morning after the morning after - Food Safety News
New York Times columnist Thomas Friedman once wrote; “Everything really important happens the morning after the morning after…”
In short, focus on what really changes, not what is said will change.
That is a good lesson for the White House and Congress to remember with the proposed “reforms” of the Food and Drug Administration’s (FDA) foods programs. Commissioner Robert Califf has promised that the structural, political, and cultural obstacles that have made FDA’s assurance of food safety ring hollow will be changed.
FDA Provides Update on Proposed Human Foods Program and Office of Regulatory Affairs Restructuring - FDA Statement
Today, the U.S. Food and Drug Administration announced that it has begun a national search for a new Deputy Commissioner for Human Foods and is providing an update on last month’s proposed restructuring of the agency’s Human Foods Program and Office of Regulatory Affairs (ORA) to enhance coordination, prevention and response activities.