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In his latest appearance before a congressional committee, FDA Commissioner Andrew von Eschenbach once again defended the agency’s approval of the controversial antibiotic Ketek, while also responding to attacks on his leadership.
Sen. Chuck Grassley (R-Iowa) is asking FDA Commissioner Andrew von Eschenbach to account for the agency’s delays in taking action on updating acetaminophen product labeling to reflect safety issues.
The FDA is proposing rules in a draft guidance that would bar any person with more than $50,000 in ties to drug and device companies from participating in an agency advisory committee.
The Clinical Data Interchange Standards Consortium (CDISC) has asked research sites and sponsors to participate in its Clinical Data Acquisition Standards Harmonization (CDASH) initiative, which has received strong backing from the FDA.
Sponsors cannot assume that a data monitoring committee (DMC) or data safety monitoring board is appropriate for every clinical trial, according to an expert.
Pediatric drug study costs increased nearly eightfold between 2000 and 2006, while the studies have become larger and more frequent, a study from the Tufts Center for the Study of Drug Development said.
Drug manufacturers choosing to submit applications to the Center for Drug Evaluation and Research (CDER) electronically -- as opposed to on paper -- will have to use a particular electronic format called the electronic common technical document (eCTD) starting Jan. 1, 2008, an FDA official said.
Two proposed rules from the FDA strike a “generally reasonable balance” between allowing patient access to investigational drugs and ensuring patient safety, although some changes still need to be made, Public Citizen said.
Reps. Henry Waxman (D-Calif.) and Edward Markey (D-Mass.) have introduced legislation they say goes further to strengthen the FDA’s drug safety review processes than the bill’s counterpart in the Senate.
Sen. Chuck Grassley (R-Iowa) said comments from FDA Commissioner Andrew von Eschenbach discourage openness within the agency and raise questions about what problems the agency might be trying to conceal.