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Establishments that make donor eligibility determinations for certain human cells, tissues and cellular and tissue-based products (HCT/P) should retest donors to ensure that faulty testing methods do not allow communicable diseases to be transmitted through these products, according to the FDA.
The FDA wants to create an electronic network to gather and share medical product safety information with healthcare professionals and patients, the agency announced.
A judge granted a motion to stop a subpoena compelling a deposition of a New England Journal of Medicine (NEJM) editor in Merck’s Vioxx litigation, saying the drug company’s actions were “abusive and arrogant.”
The FDA is sending more than 1,100 letters to pharmaceutical companies advising them to reevaluate pharmacokinetic studies conducted by contract company MDS Pharma Services because the results may be invalid.
Two drugs used to treat Parkinson’s disease may increase the risk for heart valve damage, according to two studies published in the New England Journal of Medicine (NEJM).
Northfield Laboratories reported preliminary results from a Phase III clinical trial of its blood substitute, PolyHeme, which showed more deaths among patients using the product than in the control group.
VaxGen said that HHS has terminated for default the company’s $877.5 million contract to provide 75 million doses of a modern anthrax vaccine for civilian biodefense.
The FDA’s recent warning about serious adverse events involving off-label uses of Genentech’s drug Rituxan is unlikely to have a long-term financial impact on the company, a financial analyst says.
Eli Lilly is denying assertions in two articles in TheNew York Times that claim the company’s own internal documents show that it sought to downplay increased diabetes risk from Zyprexa, its best-selling antipsychotic drug.
The Pakistani government has finalized draft legislation that would create an autonomous Drug Regulatory Authority to standardize the quality of medicines and streamline their registration.