FDA takes steps to reduce tobacco use, especially among youth, by exploring options to address the role of flavors ‒ including menthol ‒ in tobacco products.
Category Archives: Drug Safety Information Podcasts
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 U.S.
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
FDA expands approval of replacement heart valve, smallest mechanical valve size approved in the world
FDA expands approval of replacement heart valve, smallest mechanical valve size approved in the world
FDA approves new HIV treatment for patients who have limited treatment options
The FDA approved Trogarzo (ibalizumab-uiyk), a new type of antiretroviral medication for adult patients living with HIV who have tried multiple HIV medications in the past (heavily treatment-experienced) and whose HIV infections cannot be successfully treated with other currently available therapies.
FDA authorizes, with special controls, direct-to-consumer test that reports three mutations in the BRCA breast cancer genes
FDA has authorized 23andMe to market a consumer test that reports only 3 out of more than 1,000 known mutations in BRCA genes