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Drug industry representatives are expressing reservations about the FDA’s proposed plan to raise user fees to pay for certain activities that are not directly related to product application review.
The FDA, in a controversial move, is considering increasing drug user fees to pay for activities not directly related to product application reviews, including the cost of reviewing direct-to-consumer (DTC) advertisements.
Drug industry representatives expressed reservations yesterday about the FDA’s proposed plan to raise user fees to pay for certain activities that are not directly related to product application review.
With the authority for the Prescription Drug User Fee Act (PDUFA) set to expire in September 2007, the FDA has started the ball rolling on designing the next user fee program for drug products.
The FDA's drug-safety operations could be vastly improved by cutting the agency's "inappropriately close ties" to pharmaceutical firms, according to a House Democrat who plans soon to introduce legislation that would transfer the responsibility of user-fee collection away from the FDA.
Manufacturers of combination products can cut their application user fees in half if their products qualify for the “barrier to innovation” waiver established by the Prescription Drug User Fee Act (PDUFA), the FDA said in a new guidance.
Investigators, sponsors and institutional review boards (IRBs) looking to reduce the time it takes to conduct multicenter clinical research should consider implementing a centralized IRB review process, suggests a new FDA draft guidance that describes how to initiate the review strategy.
The FDA’s final guidance on good review management principles (GRMPs) for Prescription Drug User Fee Act (PDUFA) products now includes specific timelines for application review milestones — a change that will be welcomed by drugmakers, many of which criticized the initial draft document for being too vague.
Pharmaceutical firms could see changes in who oversees their products at the FDA this spring as the agency appears set to restructure the divisions and offices that handle new drugs.