In response to repeated criticism that terminally ill patients find it too difficult to obtain access to experimental and potentially life-saving drugs, the U.S. Food and Drug Administration (FDA) has announced changes to its “compassionate use” process in the hopes of making it easier for physicians to request access to medical products on behalf of their patients.
The U.S. Food and Drug Administration (FDA) could stand to lose all of its authority to regulate food products, potentially including dietary supplements, under a new proposal unveiled by President Barack Obama in early February 2015.
Hamburg’s final day at the agency will be in late March 2015, Hamburg wrote in an email. She will be succeeded on an acting basis by Stephen Ostroff, FDA’s chief scientist since January 2014.
Margaret Hamburg, one of the longest-serving commissioners in U.S. Food and Drug Administration (FDA) history, planed to announce her resignation in February 2015, FDA officials have confirmed.
The FDA promised to finalize an expedited approval pathway for medical devices that address critical unmet needs and to officially expand its authority into the regulation of lab-developed molecular diagnostic tests in its annual list of upcoming medical device-related guidance documents for the new year.
Ultrasound imaging is the most widely used medical imaging method during pregnancy. Fetal ultrasound imaging provides real-time images of the fetus. Doppler fetal ultrasound heartbeat monitors are hand-held ultrasound devices that let you listen to the heartbeat of the fetus. Both are prescription devices, designed to be used by trained health care professionals. They are not intended for over-the-counter (OTC) sale or use, and the FDA strongly discourages their use for creating fetal keepsake images and videos.
So far, the issue of MRI-safe devices has mostly focused on devices like pacemakers, and more recently cochlear implants, both of which use electronics. However, the FDA issued new guidance on the MRI compatibility–or in some cases incompatibility–of implants that do not require electrical power to service their function, such as cardiovascular stents, intracranial aneurysm clips, endovascular grafts and transprostatic tissue retractors.
The US Food and Drug Administration (FDA) has released data on the observations it makes during inspections of medical device facilities, indicating the most common issues faced by medical device companies.