Statement from FDA Commissioner Scott Gottlieb, M.D., on 2017 National Youth Tobacco Survey results and ongoing FDA efforts to protect youth from the dangers of nicotine and tobacco products
Category Archives: Drug Safety Information Podcasts
FDA seeks permanent injunction against company selling unapproved hand sanitizers that claim to prevent infections from numerous pathogens
FDA seeks permanent injunction against company selling unapproved hand sanitizers that claim to prevent infections from numerous pathogens
FDA Deputy Commissioner for Policy, Planning, Legislation, and Analysis Anna Abram, remarks prepared for testimony before a subcommittee of the U.S. House Committee on Energy and Commerce on the Pandemic and All-Hazards Preparedness Act
FDA’s Anna Abram’s testimony for U.S. House Committee on Energy and Commerce Subcommittee on Health on the Pandemic and All-Hazards Preparedness Act
FDA and USDA announce key step to advance collaborative efforts to streamline produce safety requirements for farmers
FDA and USDA announce key step to advance collaborative efforts to streamline produce safety requirements for farmers by aligning USDA program with FDA’s Produce Safety Rule requirements.
FDA takes action against 53 websites marketing unapproved opioids as part of a comprehensive effort to target illegal online sales
FDA announced that it has warned nine online networks, operating a total of 53 websites, that they must stop illegally marketing potentially dangerous, unapproved and misbranded versions of opioid medications, including tramadol and oxycodone.
FDA warns companies to stop selling dangerous and illegal pure and highly concentrated caffeine products
FDA issued warning letters to the parties responsible for liquidcaffeine.com and Dual Health Body and Mind for illegally selling certain highly concentrated caffeine products.
FDA approves first biosimilar to Neulasta to help reduce the risk of infection during cancer treatment
FDA approves Fulphila (pegfilgrastim-jmdb) as the first biosimilar to Neulasta (pegfilgrastim) to decrease the chance of infection as suggested by febrile neutropenia in patients with non-myeloid cancer.
Statement from FDA Commissioner Scott Gottlieb, M.D., on proposed modernization of FDA’s drug review office
FDA has proposed an important series of new steps to modernize the organization and functions of CDER’s Office of New Drugs.
Statement from FDA Commissioner Scott Gottlieb, M.D., on FDA’s work to mitigate shortages of intravenous drugs, shorten supply disruptions and better predict vulnerabilities
FDA’s work to mitigate shortages of intravenous drugs, shorten supply disruptions and better predict vulnerabilities
Statement from FDA Commissioner Scott Gottlieb, M.D., on new policies to reduce the ability of brand drug makers to use REMS programs as a way to block timely generic drug entry, helping promote competition and access
FDA Commissioner on new policies to reduce ability of brand drug makers to use REMS programs to block timely generic drug entry