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Even though the FDA user fee reauthorization bill is well on its way through Congress, HHS Secretary Tom Price is appealing to lawmakers to push for an increase in fees that would leave industry footing the entire bill for medical product approvals. Read More
In a letter sent Tuesday to President Trump, 11 Senate Democrats urged the White House to scrap plans for fiscal 2018 budget cuts that would affect implementation of the 21st Century Cures Act. Read More
The FDA has issued a boxed warning for Johnson & Johnson’s Invokana (canagliflozin) treatment for type 2 diabetes, describing a doubled risk of leg and foot amputations compared to placebo. In 2016, Invokana brought in more than $1.4 billion in sales. Read More
The FDA’s new commissioner, Scott Gottlieb, addressed the agency’s full staff for the first time May 15 and highlighted the agency’s key role in combating the opioid crisis. Read More
The China Food and Drug Administration is taking public comments on four proposed reforms, covering the review of new drug applications, the deregulation of clinical trials, postmarket surveillance and intellectual property rights. Read More
A bipartisan trio of senators urged the Office of Management and Budget to take administrative action to lower prescription costs — while 36 House Democrats asked President Trump to consider using FDA user fee legislation as a vehicle to cut drug prices. Read More
The FDA’s Office of Regulatory Affairs officially began its transition to a program-based structure Monday, aligning inspection staff into seven product categories — more closely mirroring the organization of the agency’s centers. Read More