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Newly minted FDA Commissioner Scott Gottlieb comes into office immediately faced with many challenges: from hiring issues to budget concerns, drug prices and a nationwide opioid addiction crisis. But those who have worked with him say he’s the ideal man for the job. Read More
The FDA’s Office of Regulatory Affairs officially began its transition to a program-based structure, aligning inspection staff into seven product categories — more closely mirroring the organization of the agency’s centers. Read More
A bill to reauthorize FDA user fees for the next five years received voice-vote approval from a House health subcommittee Thursday. The measure now heads to the full Energy and Commerce Committee for consideration. Read More
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