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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
Spain’s Agency of Medicines and Medical Devices has ordered Madrid vaccine maker Angulema to suspend manufacturing and recall drug batches over GMP deficiencies. 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
Dozens of healthcare organizations, including several drugmakers and payers, wrote an open letter to President Donald Trump, urging him and Congress to continue the pursuit of value-based care. Read More