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The FDA issued a draft guidance with recommendations on how blood product manufacturers can apply for licenses to use placental or umbilical cord blood for treatments for hematological malignancies.
The FDA wants to prohibit certain cattle material from drugs, biologics and medical devices to lower the risk of bovine spongiform encephalopathy (BSE or mad cow disease.)
Common OTC pain relievers would have to carry prominent new warnings about the potential for stomach bleeding and liver damage under an FDA-proposed rule.
Outgoing Senate Majority Leader Bill Frist’s (R-Tenn.) last-minute effort to push through the Bush administration’s choice to be the FDA commissioner was successful as the Senate voted overwhelmingly Dec. 7 to approve the nomination.
The FDA wants to create an electronic network to gather and share medical product safety information with healthcare professionals and patients, the agency announced.
The poor understanding of device performance in magnetic resonance imaging (MRI) environments means that implantable devices "remain contraindicated for use with MRI," Biophan Technologies Vice President of Engineering Jeffrey Helfer said Jan. 8.
Firms should establish special controls to ensure the safety and effectiveness of quality control (QC) materials for cystic fibrosis nucleic acid assays, the FDA said in guidance published Jan. 10.
Because all FDA centers and various regulations are involved with combination products, whatever is happening with these devices will have an impact on all other products, said Mason Diamond, vice president of clinical and regulatory affairs for TyRx Pharma.