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Device clinical trial sponsors will be subject to new requirements under U.S. Food and Drug Administration (FDA) draft guidance on the format, content and review of reports related to clinical postapproval studies.
The FDA issued a draft guidance with recommendations on how blood product manufacturers can apply for licenses to use placental or umbilical cord blood for treatments for hematological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.
A recently published FDA guidance provides detailed information on what firms need to include in premarket notification, or 510(k), applications for cord blood processing systems and storage containers.
The FDA issued draft guidance with recommendations on how blood product manufacturers can apply for licenses to use placental or umbilical cord blood for treatments for hematological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 issued the final version of its comprehensive current good manufacturing practice (cGMP) guidance Sept. 29, making "no substantive changes" from the draft released two years ago, the agency said.
The FDA issued a draft guidance with recommendations on how blood product manufacturers can apply for licenses to use placental or umbilical cord blood for treatments for hematological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.
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.
The process for IRBs to refer potentially high-risk clinical trials involving children to the FDA for special review is laid out in detail in a new guidance document.
When designing medical devices that use radio-frequency (RF) wireless technology, firms should consider how those products will interact with other devices and respond to potential electromagnetic interference (EMI), the FDA says in new draft guidance.
Manufacturers and assemblers of X-ray computed tomography equipment may use an alternate measure of the computed tomography dose index (CTDI) when scanning patients, a new U.S. Food and Drug Administration (FDA) guidance says.