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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 FDA is rejecting the notion that it should allow unapproved prescription drugs that meet category-wide safety and efficacy standards to be approved for marketing, arguing that the risks are too great and that the approach is too expensive and time-consuming.
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.)
The FDA acknowledged the need for greater transparency and an increased focus on safety in its drug review process through a series of recommendations it issued.
The FDA issued a draft guidance with recommendations on how blood product manufacturers can apply for licenses to use placental or umbilical cord blood for treatments for hematological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 warned Omnicare for inadequate quality control systems for the fifth time in 11 years, causing the company to recall its products and close its drug repackaging facility.
The FDA needs to change its labeling requirements for contraceptives to incorporate data about the drugs’ effectiveness and their noncontraceptive benefits, as well as to ensure that the labels are more readable and concise, an agency advisory committee recommended.
The FDA wants to impose new electronic reporting requirements on biological product manufacturers to assist in potential product recalls, the agency said.
Regulations established by the FDA and the United States Pharmacopeia (USP) for labeling parenteral infusion drug products leave significant gray areas that may put patients at risk, according to experts speaking at a recent NIH conference.