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Senate Finance Committee Chairman Chuck Grassley (R-Iowa) has joined the ranks of critics questioning the composition of the FDA’s newly formed Drug Safety Oversight Board (DSB).
The FDA’s accelerated approval process for drugs is “broken,” contends a top Democratic representative, who says many drug companies aren’t completing the postmarketing studies they pledged to conduct after gaining approval of their products.
The FDA’s accelerated approval process for drugs is “broken,” contends a top Democratic representative, who says a review of agency data reveals drug companies aren’t completing the postmarketing studies they promised to perform after gaining approval of their products.
The FDA is looking at active drug surveillance programs as a way to better monitor drug safety in the real world — a move that comes as one healthcare information firm plans to launch a drug registry that promises to give regulators and firms faster access to drug safety information from an 11-million-patient database.
Pharmaceutical firms are conducting significantly fewer clinical trials then they were in the 1990s, a trend reflected by a rapid decline in the number of principal investigators (PIs) in the U.S. between 2001 and 2003, according to a study completed by the Tufts Center for the Study of Drug Development (CSDD).
An FDA pilot program that aims to improve the postmarketing surveillance of medical devices could hold some lessons for the agency’s efforts to enhance oversight of marketed drugs, a top FDA drug safety official said.
The FDA’s premarketing and postmarketing safety programs from drugs and biologics will be at the top of the agenda when the agency’s Science Board convenes next month.
The SEC should take a harder look at how drugmakers disclose information about postmarketing studies to shareholders, according to a top Democratic representative.
A top Democratic representative is prodding the SEC to take a harder look at how pharmaceutical companies disclose information about postmarketing studies to shareholders.
The FDA’s Electronic Submissions Gateway moved a step closer to reality last week when the agency selected the vendors that will build the system, a central collection portal for electronic submissions from FDA-regulated industries and other government agencies.