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Combination product manufacturers can cut their application user fees by as much as 50 percent if their products qualify for the “barrier to innovation” waiver established by the Prescription Drug User Fee Act (PDUFA), according to an FDA guidance published in the April 21 Federal Register.
Manufacturers should begin submitting electronic labeling changes for previously approved drugs in structured product labeling (SPL) format by fall 2005, according to a final FDA guidance published in the April 21 Federal Register.
In a move welcomed by industry advocates, the Centers for Medicare & Medicaid Services (CMS) proposed in a new draft guidance issued earlier this month to grant coverage for promising new medical technologies upfront, requiring subsequent patient data be collected post-coverage.
Exploratory clinical trial sponsors involving drugs and therapeutic biological products have not been taking full advantage of the flexibility offered in terms of the amount of data that needs to be submitted with early exploratory investigational new drug (IND) applications, the FDA said.
Sponsors of exploratory clinical trials involving drugs and therapeutic biological products have not been taking full advantage of the flexibility offered in terms of the amount of data that needs to be submitted with early exploratory investigational new drug (IND) applications, according to the FDA.
Clinical trials professionals hope the FDA will have a new adverse event reporting system (AERS) in place before the end of next year to help streamline the reporting process, which has become increasingly onerous for researchers.
The FDA has released the first in a series of guidance documents that provide recommendations on clinical trial endpoints for the approval of cancer drugs and biologics.
The FDA has released a final guidance that describes a method for summarizing identified drug risks, particularly those found early in the postmarketing period. The guidance follows on the heels of other recommendations intended to help firms better monitor drug-safety issues.