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Press releases from FDA
Updated: 2 hours 44 min ago

Remarks from FDA Commissioner Scott Gottlieb, M.D., as prepared for testimony before U.S. House Committee on Appropriations on FDA’s Fiscal Year 2019 budget

Tue, 2018-04-17 13:06
FDA Commissioner Scott Gottlieb, M.D. remarks to the U.S. House Committee on Appropriations on the FDA’s Fiscal Year 2019 budget

FDA approves first therapy for rare inherited form of rickets, x-linked hypophosphatemia

Tue, 2018-04-17 12:20
FDA approved Crysvita (burosumab), the first drug approved to treat adults and children ages 1 year and older with x-linked hypophosphatemia (XLH), a rare form of rickets.

Statement by Dr. Susan Mayne on FDA efforts to reduce consumer exposure to arsenic in rice

Tue, 2018-04-17 11:36
One way FDA oversees food safety is through monitoring of contaminants in food, such as arsenic, assessing potential exposure and taking steps to reduce exposure

Statement from FDA Commissioner Scott Gottlieb, M.D., on new efforts to enhance and modernize the FDA’s approach to medical device safety and innovation

Tue, 2018-04-17 09:48
The FDA is releasing the Medical Device Safety Action Plan that outlines our vision for how FDA can continue to enhance our programs and processes to assure the safety of medical devices

La FDA toma medidas para proteger a los consumidores de los suplementos alimenticios que contienen niveles peligrosamente altos de cafeína altamente concentrada o pura

Fri, 2018-04-13 17:12
: El día de hoy, la Administración de Alimentos y Medicamentos de los Estados Unidos (FDA, por sus siglas en inglés) tomó una medida importante para proteger mejor a los consumidores de los peligros de los productos de cafeína altamente concentrada y pura.

FDA takes step to protect consumers against dietary supplements containing dangerously high levels of extremely concentrated or pure caffeine

Fri, 2018-04-13 07:57
Today, the U.S. Food and Drug Administration took an important step to better protect consumers from the dangers of highly concentrated and pure caffeine products.

FDA finalizes guidances to accelerate the development of reliable, beneficial next generation sequencing-based tests

Thu, 2018-04-12 09:20
The FDA today finalized two guidances to drive the efficient development of a novel technology that scans a person’s DNA to diagnose genetic diseases, which are usually hereditary, and guide medical treatments.

FDA permits marketing of artificial intelligence-based device to detect certain diabetes-related eye problems

Wed, 2018-04-11 10:18
FDA permits marketing of first medical device to use artificial intelligence to detect greater than a mild level of diabetic retinopathy in the eye of adults who have diabetes.

FDA clears first contact lens with light-adaptive technology

Tue, 2018-04-10 12:44
FDA clears first contact lens with additive that automatically darkens the lens when exposed to bright light

FDA restricts sale and distribution of Essure to protect women and to require that patients receive risk information

Mon, 2018-04-09 11:01
FDA is restricting the sale and distribution of the Essure device to only those health care providers who provide information to women about the risks and benefits of this device before they get the permanent contraception implant.

FDA orders mandatory recall for kratom products due to risk of salmonella

Tue, 2018-04-03 09:21
Today, the U.S. Food and Drug Administration announced it has issued a mandatory recall order for all food products containing powdered kratom manufactured, processed, packed, or held by Triangle Pharmanaturals LLC, after several were found to contain salmonella. The agency took this action after the company failed to cooperate with the FDA’s request to conduct a voluntary recall. This is the first time the agency has issued a mandatory recall order to protect Americans from contaminated food products.

New York raw milk cheese company ordered to stop sales for food safety violations

Mon, 2018-04-02 09:56
FDA announces an enforcement action taken against Vulto Creamery of New York. The company cannot sell ready-to-eat raw cheese product until it complies with the consent decree. Vulto was linked to an outbreak last year.

Statement from FDA Commissioner Scott Gottlieb, M.D., on FDA’s efforts to enhance the patient perspective and experience in drug development and review

Fri, 2018-03-30 08:08
FDA issues update to Benefit-Risk Assessment plan as part of efforts to enhance the patient perspective and experience in drug development and review

FDA expands approval of Blincyto for treatment of a type of leukemia in patients who have a certain risk factor for relapse

Thu, 2018-03-29 12:26
FDA expands approval of Blincyto for treatment of a type of leukemia in patients who have a certain risk factor for relapse

Federal judge approves consent decree with New York dietary supplement manufacturer Riddhi USA

Thu, 2018-03-29 09:37
A New York dietary supplement manufacturer has been ordered by a federal court to stop selling its products until the company comes into compliance with the FDA’s dietary supplement manufacturing regulations.

Federal judge approves consent decree with Florida company that sold unapproved new drugs and misbranded drugs

Wed, 2018-03-28 09:42
Federal judge approves consent decree with Florida company that sold unapproved new drugs and misbranded drugs

FDA authorizes first fully interoperable continuous glucose monitoring system, streamlines review pathway for similar devices

Tue, 2018-03-27 14:14
The authorization classifies integrated continuous glucose monitoring devices in class II and subjects them to certain criteria called special controls

Statement from FDA Commissioner Scott Gottlieb, M.D., on a key step in advancing FDA’s oversight of drug compounding and implementing new laws governing outsourcing facilities

Fri, 2018-03-23 09:34
Statement from FDA Commissioner Scott Gottlieb, M.D., on a key step in advancing FDA’s oversight of drug compounding and implementing new laws governing outsourcing facilities

Statement from FDA’s Donald St. Pierre on findings from ongoing investigation into lead testing issues

Thu, 2018-03-22 13:41
FDA on findings from ongoing investigation into lead testing issues; studies find chemical interaction during test processing may contribute to skewing results

FDA expands approval of Adcetris for first-line treatment of Stage III or IV classical Hodgkin lymphoma in combination with chemotherapy

Tue, 2018-03-20 13:31
FDA approves Adcetris (brentuximab vedotin) to treat adult patients with previously untreated stage III or IV classical Hodgkin lymphoma (cHL) in combination with chemotherapy

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