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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
Fifty-two representatives and nine senators sent letters to HHS Secretary Tom Price and CMS Administrator Seema Verma, urging them to reverse current Medicare policy for the reimbursement for biosimilar products. Read More
The U.K.’s Medicines and Healthcare products Regulatory Agency laid out its top 10 priorities for 2017 and 2018 — including developing a model for the agency’s future, post-Brexit. Read More
The Senate HELP Committee on Thursday advanced to the full Senate a bill that would reauthorize FDA user fees through 2022. The vote was 21-2. Read More