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All "unanticipated problems" affecting participants in clinical trials sponsored or supported by HHS must be reported, a new guidance from the Office for Human Research Protections (OHRP) says.
The FDA needs to change the way it studies and labels contraceptives to ensure more accurate findings and more effective use of these products, an agency advisory committee found.
The FDA has announced two major personnel changes, moving Janet Woodcock to oversee a new office and inserting John Dyer as deputy commissioner for operations and chief operating officer of the agency.
Rep. Rosa DeLauro (D-Conn.), the incoming chairwoman of the subcommittee with jurisdiction over the FDA’s budget, has a number of changes in mind for the agency, starting with an improved drug review system, the lawmaker says.
The FDA warned Stem Cell Pharma for implanting stem cells in test subjects without following any standard operating procedures (SOPs) and without an approved license.
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.
In one of the first oversight actions of the new Congress, members of the House Committee on Energy and Commerce released a letter sent to FDA Commissioner Andrew von Eschenbach announcing an inquiry into one of the agency’s contracts.
The FDA needs to change its labeling requirements for contraceptives to incorporate data about the drugs’ effectiveness and its noncontraceptive benefits, as well as to ensure that the labels are more readable and concise, an agency advisory committee recommended.
An FDA advisory committee is recommending that the agency fundamentally change the way it tests new contraceptives to focus on comparative drug studies.