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The FDA has sent Congress its final recommendations for the reauthorization of the Prescription Drug User Fee Act (PDUFA), including an increase in user fees to pay for drug safety reviews as well as reviews of direct-to-consumer (DTC) advertising.
GE Healthcare Technologies has reassigned more than 60 employees to address alleged current good manufacturing practice (cGMP) violations related to breast biopsy plates and magnetic resonance imaging (MRI) system coils identified in a recent FDA warning letter, Brian McKaig, a spokesman for the company, told D&DL.
The FDA expects biliary stent makers to submit their plans for reducing off-label use of their devices “in several weeks,” a Boston Scientific spokesman said.
The FDA is proposing in a draft guidance to bar any person with more than $50,000 in ties to medical device and drug companies from participating in an agency advisory committee.
Sen. Chuck Grassley (R-Iowa) is asking FDA Commissioner Andrew von Eschenbach to account for the agency’s delays in taking action on updating acetaminophen product labeling to reflect safety issues.
Two proposed rules from the FDA strike a “generally reasonable balance” between allowing patient access to investigational drugs and ensuring patient safety, although some changes still need to be made, Public Citizen said.
Recent remarks made by FDA Commissioner Andrew von Eschenbach suggesting that follow-on biologics are not interchangeable with their brand counterparts drew sharp criticism from some generic firms, who view that statement as creating a double standard.
FDA Commissioner Andrew von Eschenbach’s establishment of a new Office of Integrity and Accountability to address cultural issues within the agency might be a “nice” idea but is not necessary for accomplishing the FDA’s mission, according to Peter Pitts, director of the Center for Medicine in the Public Interest (CMPI).
In his latest appearance before a congressional committee, FDA Commissioner Andrew von Eschenbach once again defended the agency’s approval of the controversial antibiotic Ketek, while also responding to attacks on his leadership.
The FDA is proposing rules in a draft guidance that would bar any person with more than $50,000 in ties to drug and device companies from participating in an agency advisory committee.