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Press releases from FDA
Updated: 4 hours 35 min ago

FDA warns Magellan Diagnostics of significant violations of the law as part of investigation into lead testing issues

6 hours 28 min ago
Today the U.S. Food and Drug Administration issued a warning letter to Magellan Diagnostics Inc. for several violations of federal law, including marketing significantly modified versions of two of its blood lead testing systems without the FDA’s required clearance or approval and failing to submit medical device reports to the FDA after becoming aware of customer complaints involving discrepancies in blood lead test results.
Categories: FDA News

Statement by FDA Commissioner Scott Gottlieb, M.D. on medical device manufacturing recovery in Puerto Rico

Fri, 10/20/2017 - 08:19
Statement by FDA Commissioner Scott Gottlieb, M.D. on medical device manufacturing recovery in Puerto Rico
Categories: FDA News

FDA approves CAR-T cell therapy to treat adults with certain types of large B-cell lymphoma

Wed, 10/18/2017 - 15:37
The U.S. Food and Drug Administration today approved Yescarta (axicabtagene ciloleucel), a cell-based gene therapy, to treat adult patients with certain types of large B-cell lymphoma who have not responded to or who have relapsed after at least two other kinds of treatment. Yescarta, a chimeric antigen receptor (CAR) T cell therapy, is the second gene therapy approved by the FDA and the first for certain types of non-Hodgkin lymphoma (NHL).
Categories: FDA News

FDA clears new robotically-assisted surgical device for adult patients

Fri, 10/13/2017 - 14:14
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.
Categories: FDA News

California dietary supplement maker, Custompax prohibited from manufacturing

Fri, 10/13/2017 - 10:14
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.
Categories: FDA News

Statement by FDA Commissioner Scott Gottlieb, M.D. on Baxter manufacturing recovery in Puerto Rico

Fri, 10/13/2017 - 06:31
Statement by FDA Commissioner Scott Gottlieb, M.D. on Baxter manufacturing recovery in Puerto Rico
Categories: FDA News

FDA clears first 7T magnetic resonance imaging device

Thu, 10/12/2017 - 08:45
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.
Categories: FDA News

Statement by FDA Commissioner Scott Gottlieb, M.D. on new steps by FDA to advance patient engagement in the agency’s regulatory work

Wed, 10/11/2017 - 09:52
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.
Categories: FDA News

FDA approves implantable device to treat moderate to severe central sleep apnea

Fri, 10/06/2017 - 14:55
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.
Categories: FDA News

Statement from FDA Commissioner Scott Gottlieb, M.D. on FDA’s continued assistance following the natural disaster in Puerto Rico

Fri, 10/06/2017 - 13:23
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.
Categories: FDA News

FDA awards 15 grants for clinical trials to stimulate product development for rare diseases

Fri, 10/06/2017 - 08:33
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.
Categories: FDA News

FDA awards six grants for natural history studies in rare diseases

Fri, 10/06/2017 - 08:32
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 natural history models to augment the need for placebo arms in studies of drugs that target very rare disease, where trial recruitment can be challenging.
Categories: FDA News

FDA approves first test for screening Zika virus in blood donations

Thu, 10/05/2017 - 15:04
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.
Categories: FDA News

Statement from FDA Commissioner Scott Gottlieb, M.D., on the FDA’s Adverse Event Reporting System (FAERS) and new search tool

Mon, 10/02/2017 - 10:07
Statement from FDA Commissioner Scott Gottlieb, M.D., on the FDA’s Adverse Event Reporting System (FAERS) and new search tool
Categories: FDA News

FDA improves access to reports of adverse drug reactions

Thu, 09/28/2017 - 13:35
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.
Categories: FDA News

FDA approves new treatment for certain advanced or metastatic breast cancers

Thu, 09/28/2017 - 12:06
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).
Categories: FDA News

FDA approves first continuous glucose monitoring system for adults not requiring blood sample calibration

Wed, 09/27/2017 - 14:51
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”).
Categories: FDA News

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

Tue, 09/26/2017 - 14:31
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
Categories: FDA News

Federal judge orders Flawless Beauty to stop distributing unapproved drugs, recall certain products

Tue, 09/26/2017 - 13:40
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.
Categories: FDA News

FDA selects participants for new digital health software precertification pilot program

Tue, 09/26/2017 - 09:57
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.
Categories: FDA News