The FDA issued draft guidance, Clinical Trial Considerations to Support Accelerated Approval of Oncology Therapeutics, regarding clinical trial design considerations to support accelerated approval applications.
“Diet-related chronic diseases, are the leading causes of death and disability in the U.S.
Manufacturer Must Monitor Consumer Impact; FDA May Withdraw Authorization as Needed to Protect Public Health Today, the U.S. Food and Drug Administration authorized U.S. Smokeless Tobacco Company’s...
Company Must Stop Marketing Unauthorized Products Today, the U.S. Food and Drug Administration issued marketing denial orders (MDOs) for two menthol e-cigarette products currently marketed by R.J. Reynolds...
Today, the U.S. Food and Drug Administration announced it is requesting $7.2 billion as part of the president’s fiscal year (FY) 2024 budget. This funding will...
Agency Aims to Maintain Availability for Legitimate Use in Animals while Preventing Importation for Illicit Purposes Today, the U.S. Food and Drug Administration announced that it...
Agency Continues Its Commitment to Increase Availability of Home Diagnostic Tests Today, the U.S. Food and Drug Administration issued an emergency use authorization (EUA) for the first over-the-counter...
The U.S. Food and Drug Administration’s Center for Tobacco Products (CTP) outlined the steps it plans to take in response to an external evaluationExternal Link Disclaimer I commissioned last year...
Action Is the First of its Kind Against Manufacturers Violating the Law Today, the U.S. Food and Drug Administration announced it has filed civil money penalty (CMP)...
Addressing the drug overdose crisis and substance use disorder (SUD) is an issue of great concern for our nation and remains a top public health priority...