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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.
An FDA advisory committee is recommending that the agency fundamentally change standards for testing new contraceptives to focus on comparative drug studies.
Public Citizen has filed a petition asking the FDA to ban third-generation oral contraceptives containing desogestrel, saying the pills double the risk of blood clots compared with pills without the ingredient, while not having any clinical benefit over older medications.
While recent Centers for Disease Control and Prevention (CDC) data show an increase in the number of adolescent suicides since black box warnings were added to some types of antidepressants, there may not be enough data to link the two, a government source says.
The Bush administration is not providing sufficient funding or making the argument for the FDA’s effort to improve drug development, known as the Critical Path Initiative, observers say.
The U.S. Food and Drug Administration (FDA) wants to ban certain cattle materials from medical devices, drugs and biologics to lower the risk of bovine spongiform encephalopathy (BSE, or mad cow disease).
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and respond to potential electromagnetic interference (EMI), the U.S. Food and Drug Administration (FDA) says in new draft guidance.
Device clinical trial sponsors will be subject to new requirements under U.S. Food and Drug Administration (FDA) draft guidance on the format, content and review of reports related to clinical postapproval studies.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 acknowledged the need for greater transparency and an increased focus on safety in its drug review process through a series of recommendations it issued.
Barr Pharmaceuticals and its subsidiary Pliva have won final FDA approval to manufacture and market injectable azithromycin, a generic version of Pfizer's Zithromax.