FDA clears new robotically-assisted surgical device for adult patients
Today, the U.S. Food and Drug Administration cleared the Senhance System, a new robotically-assisted surgical device (RASD) that can help facilitate minimally invasive surgery.
Archive for the ‘Drug Recalls & Safety Notices’ category
California dietary supplement maker, Custompax prohibited from manufacturing
A California dietary supplement manufacturer recently was ordered by a federal court to stop selling its products until the company comes into compliance with the U.S. Food and Drug Administration’s dietary supplement manufacturing regulations and other requirements listed in a consent decree.
Statement by FDA Commissioner Scott Gottlieb, M.D. on Baxter manufacturing recovery in Puerto Rico
Statement by FDA Commissioner Scott Gottlieb, M.D. on Baxter manufacturing recovery in Puerto Rico
FDA clears first 7T magnetic resonance imaging device
Today, the U.S. Food and Drug Administration cleared the first seven tesla (7T) magnetic resonance imaging (MRI) device, more than doubling the static magnetic field strength available for use in the United States. The Magentom Terra is the first 7T MRI system cleared for clinical use in the United States.
Statement by FDA Commissioner Scott Gottlieb, M.D. on new steps by FDA to advance patient engagement in the agency’s regulatory work
The Food and Drug Administration is hosting a pioneering event today: the first meeting of the Patient Engagement Advisory Committee or PEAC. It’s a significant step forward in the FDA’s efforts to broaden its engagement with patients – and to deepen the involvement of patients in our regulatory activities.
FDA approves implantable device to treat moderate to severe central sleep apnea
The U.S. Food and Drug Administration today approved a new treatment option for patients who have been diagnosed with moderate to severe central sleep apnea. The Remedē System is an implantable device that stimulates a nerve located in the chest that is responsible for sending signals to the diaphragm to stimulate breathing.
Statement from FDA Commissioner Scott Gottlieb, M.D. on FDA’s continued assistance following the natural disaster in Puerto Rico
FDA continues extensive efforts to provide direct assistance to the residents of Puerto Rico following Hurricanes Irma and Maria, and is taking new steps to mitigate the impact of these twin disasters on the island’s vibrant medical product manufacturing sector. Our top priority is the people of Puerto Rico.
FDA awards 15 grants for clinical trials to stimulate product development for rare diseases
The U.S. Food and Drug Administration today announced that it has awarded 15 new clinical trial research grants totaling more than $22 million over the next four years to boost the development of products for patients with rare diseases. These new grants were awarded to principal investigators from academia and industry across the country.
FDA awards six grants for natural history studies in rare diseases
The U.S. Food and Drug Administration today announced it has awarded six new research grants for natural history studies in rare diseases. The aim of the research is to inform medical product development by better understanding how specific rare diseases progress over time. One potential application of these studies is the opportunity to eventually use […]
FDA approves first test for screening Zika virus in blood donations
The U.S. Food and Drug Administration today approved the cobas Zika test, a qualitative nucleic acid test for the detection of Zika virus RNA in individual plasma specimens obtained from volunteer donors of whole blood and blood components, and from living organ donors.
Statement from FDA Commissioner Scott Gottlieb, M.D., on the FDA’s Adverse Event Reporting System (FAERS) and new search tool
Statement from FDA Commissioner Scott Gottlieb, M.D., on the FDA’s Adverse Event Reporting System (FAERS) and new search tool
FDA improves access to reports of adverse drug reactions
The U.S. Food and Drug Administration today launched a new user-friendly search tool that improves access to data on adverse events associated with drug and biologic products through the FDA’s Adverse Event Reporting System (FAERS). The tool is designed to make it easier for consumers, providers, and researchers to access this information.
FDA approves new treatment for certain advanced or metastatic breast cancers
The U.S. Food and Drug Administration today approved Verzenio (abemaciclib) to treat adult patients who have hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer that has progressed after taking therapy that alters a patient’s hormones (endocrine therapy).
FDA approves first continuous glucose monitoring system for adults not requiring blood sample calibration
The U.S. Food and Drug Administration today approved the FreeStyle Libre Flash Glucose Monitoring System, the first continuous glucose monitoring system that can be used by adult patients to make diabetes treatment decisions without calibration using a blood sample from the fingertip (often referred to as a “fingerstick”).
Statement from FDA Commissioner Scott Gottlieb, M.D., on new efforts to encourage compounding of better quality drugs under DQSA and help health care professionals access compounded medications needed for patient care from outsourcing facilities
Statement from FDA Commissioner Scott Gottlieb, M.D., on new efforts to encourage compounding of better quality drugs under DQSA and help health care professionals access compounded medications needed for patient care from outsourcing facilities
Federal judge orders Flawless Beauty to stop distributing unapproved drugs, recall certain products
A federal judge ordered a New Jersey company that sold injectable skin whitening and other beauty products to stop selling and recall some of its products because they are unapproved new drugs that may be unsafe, putting consumers at risk.
FDA selects participants for new digital health software precertification pilot program
Today, the U.S. Food and Drug Administration announced the names of the companies selected to participate in a first-of-its kind pilot program that will help revolutionize digital health regulation in the U.S.
Statement from FDA Commissioner Scott Gottlieb, M.D., on FDA actions to bring relief to citizens of Puerto Rico; to help the island recover its considerable and economically vital medical product manufacturing base; and to prevent critical shortages of life-saving drugs made in Puerto Rico
As an agency dedicated to promoting public health, and as fellow Americans, the staff at the U.S. Food and Drug Administration is doing all it can to support the immediate needs of Puerto Ricans following the destruction of Hurricane Maria. First and foremost, these efforts are focused around our mission driven responsibilities to ensure the […]
FDA conducts major global operation to protect consumers from potentially dangerous prescription drugs sold online
The U.S. Food and Drug Administration, in partnership with international regulatory and law enforcement agencies, recently took action against more than 500 websites that illegally sell potentially dangerous, unapproved versions of prescription medicines, including opioids, antibiotics and injectable epinephrine products to American consumers.