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The FDA intends to conduct timely reviews of drugmakers' postmarketing commitment protocols, according to a new guidance on streamlining postmarket reporting procedures.
Know what you want your product label to say, get a handle on quality management early on, and have an overarching strategy before conducting clinical trials — even if it’s rough and you have to make changes.
Current policies on disclosing conflicts of interest lean more toward protecting researchers from legal liability, and less toward informing patients or proving transparency, according to a review of practices at academic medical centers.
Texas-based LDR Spine received an investigational device exemption (IDE) from the FDA to conduct clinical trials with their Mobi-C artificial cervical disc, the company announced Feb. 1.
Two years after launching various pilot projects, the Biomedical Research Integrated Domain Group (BRIDG) teams have demonstrated that its technology and approach do work and will allow improved edata exchange interoperability over the full life cycle of clinical trials, experts said.
Bayer Pharmaceutical's Trasylol for treating blood-loss doubles a patient's risk of kidney failure and increases risks of heart attack, heart failure and stroke, according to a study published in the New England Journal of Medicine (NEJM).
The FDA has announced that it will not impose restrictions on “IRB shopping,” a practice in which clinical trial sponsors submit trial research to institutional review boards (IRBs) that they feel are likely to approve the trial. The agency’s statement was published in the Jan. 17 Federal Register.
Merck’s attorneys issued subpoenas to editors from the New England Journal of Medicine (NEJM) to testify in the company’s upcoming Vioxx trials, the Associated Press reported.
People who lack a cell surface protein called CCR5 are highly resistant to infection by HIV but may be at increased risk of developing West Nile virus (WNV) illness when exposed to the mosquito-borne virus, report researchers from the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH).