FDA clears first contact lens with light-adaptive technology
FDA clears first contact lens with additive that automatically darkens the lens when exposed to bright light
Archive for the ‘Drug Recalls & Safety Notices’ category
FDA restricts sale and distribution of Essure to protect women and to require that patients receive risk information
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
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 […]
New York raw milk cheese company ordered to stop sales for food safety violations
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
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
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
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
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
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
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
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
FDA approves Adcetris (brentuximab vedotin) to treat adult patients with previously untreated stage III or IV classical Hodgkin lymphoma (cHL) in combination with chemotherapy
Statement from FDA Commissioner Scott Gottlieb, M.D., on efforts to reduce tobacco use, especially among youth, by exploring options to address the role of flavors ‒ including menthol ‒ in tobacco products
FDA takes steps to reduce tobacco use, especially among youth, by exploring options to address the role of flavors ‒ including menthol ‒ in tobacco products.
Statement from FDA Commissioner Scott Gottlieb, M.D., on pivotal public health step to dramatically reduce smoking rates by lowering nicotine in combustible cigarettes to minimally or non-addictive levels
FDA takes pivotal public health step to dramatically reduce smoking rates by lowering nicotine in combustible cigarettes to minimally or non-addictive levels.
FDA warns duodenoscope manufacturers about failure to comply with required postmarket surveillance studies to assess contamination risk
FDA has issued warning letters to Olympus, FujiFilm and Pentax, for failing to comply with section 522 orders on postmarket surveillance studies for duodenoscopes
Remarks from FDA Commissioner Scott Gottlieb, M.D., as prepared for oral testimony before the U.S. House Committee on Energy and Commerce Subcommittee on Oversight and Investigations hearing “Examining U.S. Public Health Preparedness for and Response Efforts to Seasonal Influenza.”
Commissioner remarks as prepared for testimony at the hearing “Examining U.S. Public Health Preparedness for and Response Efforts to Seasonal Influenza.”
Statement from FDA Commissioner Scott Gottlieb, M.D., on effort to help bolster U.S. shellfish market by taking mutually beneficial steps to resume shellfish trade with the EU
FDA announces proposed shellfish equivalence determination with the EU that will create new market access for U.S. exporters as well as make a wider selection of healthy and safe shellfish options available to consumers. It will also assure American consumers that imported molluscan shellfish from Europe is as safe as what we produce in the […]
Statement from FDA Commissioner Scott Gottlieb, M.D., on FDA activities related to the ongoing post-market review of Essure and FDA’s commitment to keep women informed
The FDA is actively evaluating a significant increase in the number of medical device reports submitted to the agency on the Essure device from October to December 2017
FDA approves first tests to screen for tickborne parasite in whole blood and plasma to protect the U.S. blood supply
FDA approves first tests to screen for tickborne parasite in blood donations