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A pair of prominent House Democrats introduced legislation Feb. 16 that would prevent government officials from tampering with federal research and scientific policymaking.
A pair of prominent House Democrats introduced legislation Feb. 16 that would prevent government officials from tampering with federal research and scientific policymaking.
Two drug giants squared off yesterday over the question of whether the increased cardiovascular (CV) risks associated with Cox-2 inhibitor drugs are unique to certain products or are found across the entire class of pain treatments.
While the number of new molecular entities (NMEs) approved by the FDA has increased in recent years, drug researchers believe it’s getting harder to develop drugs and get approvals for their products, according to a new survey.
The FDA is eager for industry to implement the Clinical Data Interchange Standards Consortium (CDISC) Study Data Tabulation Model (SDTM) so reviewers can gain experience with the standard, but industry has been slow to respond, FDA officials said at a Feb. 1 public meeting at agency headquarters in Rockville, Md.
Pfizer’s painkiller Celebrex received a vote of confidence this week in the form of a new Canadian study that showed the drug posed no increased risk of a first heart attack in elderly patients.
Safety questions have been raised about the antistroke drug Plavix — one of the world’s top-selling brands — following the release of new clinical research that shows the drug might cause a high rate of recurrent ulcers.
Aiming to ensure healthcare providers have ready access to study results and new information, Roche will post results from key clinical research studies online by the end of the first quarter of fiscal 2005, the company said Jan. 21.
FDA drug safety reviewers should have a new data mining tool this spring to help them evaluate the hundreds of thousands of reports submitted annually to the Adverse Events Reporting System (AERS) — a system that is now more widely available to the public online.
The use of anti-inflammatory Cox-2 inhibitor drugs could increase the risk of serious cardiovascular events in humans, according to two new clinical studies.