Eight Democratic senators have sent a letter to the FDA, airing their concerns over the effects of the government-wide hiring freeze on the agency’s mission. Read More

The FDA and other government agencies are being ordered to identify two regulations to be eliminated for each new one they propose and to reconsider the industry’s costs of compliance, according to an executive order issued by President Donald Trump. Read More

The FDA had to postpone meetings with Capitol Hill staff to discuss upcoming user fee legislation, after the Trump Administration directed agencies to halt correspondence with members of Congress. Read More

Small businesses sponsoring approved generics can expect a 90 percent discount on annual user fees, offering them some relief when GDUFA II takes effect in fiscal 2018. Read More