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FDA authorized the first test to identify the emerging pathogen Candida auris, which can cause serious infections in hospitalized patients.

FDA announces new steps to encourage more widespread innovation and development of new treatments for opioid use disorder

FDA announces new steps to encourage and support the development of treatment options for people with opioid use disorder

Cantrell Drug Company prohibited from manufacturing and distributing sterile drug products in violation of the law

FDA Commissioner Scott Gottlieb, M.D. remarks to the U.S. House Committee on Appropriations on the FDA’s Fiscal Year 2019 budget

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.

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

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

: 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.

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.

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 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 additive that automatically darkens the lens when exposed to bright light

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.

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.

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.

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

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