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A new report finds that most Americans think the FDA should have more authority over drug companies to enhance drug safety comes as Congress discusses several bills that would change the agency's standards. Read More
FDA Commissioner Andrew von Eschenbach told attendees at an April 12 industry conference that the agency needs to face “a new reality” and become a better bridge between new treatments and patients.
PhRMA voiced opposition to proposed legislation that would create a pathway for the FDA to approve follow-on biologics because it will not ensure patient safety and will hinder innovation, the group said. While PhRMA does support a regulatory pathway for the products, the proposed bill does not ensure the best process for the FDA or consumers, the group added.
Sen. Edward Kennedy (D-Mass.) introduced the Prescription Drug User Fee Act (PDUFA) reauthorization last week, proposing a new structure that would increase the agency’s user fees by more than $100 million.
FDA Commissioner Andrew von Eschenbach told attendees at an April 12 industry conference that the agency needs to face “a new reality” and become a better bridge between new treatments and patients.
Sen. Edward Kennedy (D-Mass.) introduced the Prescription Drug User Fee Act (PDUFA) reauthorization this week, proposing a new structure that would increase the agency’s user fees by more than $100 million.
Two leading House members sent a letter to FDA Commissioner Andrew von Eschenbach asking him when he would have to alert agency employees about possible layoffs if the Prescription Drug User Fee Act (PDUFA) is not reauthorized.
Two leading House members sent a letter to FDA Commissioner Andrew von Eschenbach asking him when he would have to alert agency employees about possible layoffs if the Prescription Drug User Fee Act (PDUFA) is not reauthorized.
While the FDA’s recommendations for the reauthorization of the Prescription Drug User Fee Act (PDUFA) would cover the agency’s needs, Congress should consider appropriating more funds so the agency does not rely so much on user fees, PhRMA CEO Billy Tauzin said.
The Prescription Drug User Fee Act (PDUFA) pressures the FDA to review drugs on too-tight deadlines and encourages the agency to put the public’s interest second to the industry’s, witnesses at a House subcommittee hearing said.