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Press releases from FDA
Updated: 1 hour 14 sec ago

FDA warns companies marketing unproven products, derived from marijuana, that claim to treat or cure cancer

Wed, 2017-11-01 11:14
FDA warns companies marketing unproven products, derived from marijuana, that claim to treat or cure cancer

FDA reaches agreement with automatic external defibrillator manufacturer over quality control issues

Wed, 2017-11-01 08:35
FDA reaches agreement with automatic external defibrillator manufacturer over quality control issues

FDA approves new treatment for adults with mantle cell lymphoma

Tue, 2017-10-31 10:54
The U.S. Food and Drug Administration today granted accelerated approval to Calquence (acalabrutinib) for the treatment of adults with mantle cell lymphoma who have received at least one prior therapy.

FDA takes unprecedented step toward more efficient global pharmaceutical manufacturing inspections

Tue, 2017-10-31 10:15
The U.S. Food and Drug Administration has determined the agency will recognize eight European drug regulatory authorities as capable of conducting inspections of manufacturing facilities that meet FDA requirements. The eight regulatory authorities found to be capable are those located in: Austria, Croatia, France, Italy, Malta, Spain, Sweden and the United Kingdom.

Statement from FDA Commissioner Scott Gottlieb, M.D., on new strategies for addressing the crisis of opioid addiction through innovation in packaging, storage and disposal

Mon, 2017-10-30 15:48
Statement by FDA Commissioner Gottlieb on new strategies for addressing the opioid addiction crisis.

Statement from Susan Mayne, Ph.D., on proposal to revoke health claim that soy protein reduces risk of heart disease

Mon, 2017-10-30 09:39
Statement from Susan Mayne, Ph.D., on proposal to revoke health claim that soy protein reduces risk of heart disease

Statement from FDA Commissioner Scott Gottlieb, M.D., on the Trump Administration’s important efforts to address the opioid crisis

Thu, 2017-10-26 15:29
Today the Administration took a historic step to direct additional resources to help address the staggering human and economic toll created by the epidemic of opioid addiction.

Remarks from FDA Commissioner Scott Gottlieb, M.D., as prepared for oral testimony before the House Committee on Energy and Commerce Hearing, “Federal Efforts to Combat the Opioid Crisis: A Status Update on CARA and Other Initiatives

Wed, 2017-10-25 09:45
Remarks from FDA Commissioner Scott Gottlieb, M.D., as prepared for oral testimony before the House Committee on Energy and Commerce Hearing, “Federal Efforts to Combat the Opioid Crisis: A Status Update on CARA and Other Initiatives

Statement from FDA Commissioner Scott Gottlieb, M.D., on new steps to advance medical device innovation and help patients gain faster access to beneficial technologies

Tue, 2017-10-24 10:30
Enabling patients and providers to have efficient access to new and innovative medical products that meet the FDA’s gold standard for safety and effectiveness is a core part of our mission. We’re advancing these goals as part of the Medical Innovation Access Plan that I announced earlier this year. While we’ve unveiled parts of that plan already, we’ll be releasing its full detail shortly. As one part of that effort, we’re announcing some additional steps we’re taking right now to promote beneficial medical device innovation.

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

Mon, 2017-10-23 12:48
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.

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

Fri, 2017-10-20 09:19
Statement by FDA Commissioner Scott Gottlieb, M.D. on medical device manufacturing recovery in Puerto Rico

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

Wed, 2017-10-18 16:37
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).

FDA clears new robotically-assisted surgical device for adult patients

Fri, 2017-10-13 15:14
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.

California dietary supplement maker, Custompax prohibited from manufacturing

Fri, 2017-10-13 11:14
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.

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

Fri, 2017-10-13 07:31
Statement by FDA Commissioner Scott Gottlieb, M.D. on Baxter manufacturing recovery in Puerto Rico

FDA clears first 7T magnetic resonance imaging device

Thu, 2017-10-12 09:45
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.

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

Wed, 2017-10-11 10:52
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.

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

Fri, 2017-10-06 15:55
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.

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

Fri, 2017-10-06 14:23
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.

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

Fri, 2017-10-06 09:33
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.

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