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The FDA’s rush to meet drug review timelines under the Prescription Drug User Fee Act (PDUFA) may lead to more postmarketing safety problems, a Harvard University professor said.
The FDA’s rush to meet drug review timelines under the Prescription Drug User Fee Act (PDUFA) may lead to more postmarketing safety problems, a Harvard University professor said.
A senior FDA official’s speech urging the agency to pull back from requiring risk management plans as a part of the drug approval process signals a major change in the FDA’s thinking on drug safety, an industry observer says.
The FDA is focusing on improved use of epidemiological data and assessment of risk management plans (RMP) as two of the touchstones of its ongoing Prescription Drug User Fee Act (PDUFA) negotiations, a high-ranking agency official said.
The FDA wants two major reforms to its prescription drug user fee program: the ability to use industry fees for an extended postmarket review period and a formula for tying fees to the amount of work the agency must do, a high-ranking FDA official says.
The Senate committee that oversees the FDA hasn’t decided whether it will support the agency’s proposed industry user fee for reinspections of manufacturing facilities, questioning what it sees as a “unique” approach to increasing FDA funding.
The drug industry may be changing its position on whether user fees should be increased to fund activities not directly related to product application reviews, potentially supporting fee hikes to pay for improved risk communication.
Lawmakers will investigate a wide range of issues involving the FDA’s drug review and national security policies as part of Congress’ effort to reauthorize the Prescription Drug Use Fee Act (PDUFA), according to a key House staffer.
The drug industry may be changing its position on whether user fees should be increased to fund activities not directly related to product application reviews, potentially supporting fee hikes to pay for improved risk communication.
Lawmakers will investigate a wide range of issues involving the FDA’s drug review and national security policies as part of Congress’ effort to reauthorize the Prescription Drug Use Fee Act (PDUFA), according to a key House staffer.