The U.S. Department of Agriculture (USDA), the U.S. Environmental Protection Agency (EPA), and the U.S. Food and Drug Administration (FDA) today announced the signing of a joint agency formal agreement under the “Winning on Reducing Food Waste” initiative.
Category Archives: Drug Safety Information Podcasts
FDA and DHS increase coordination of responses to medical device cybersecurity threats under new partnership; a part of the two agencies’ broader effort to protect patient safety
FDA and DHS announce partnership to address medical device cybersecurity threats
Statement by FDA Commissioner Scott Gottlieb, M.D., on FDA’s new steps to modernize drug development, improve efficiency and promote innovation of targeted therapies
FDA issues two guidance documents to provide drug developers greater clarity and direction as they pursue the next generation of therapies and treatments for patients.
FDA advances investigation into whether more than 40 e-cigarette products are being illegally marketed and outside agency’s compliance policy
FDA advances investigation into whether more than 40 e-cigarette products are being illegally marketed and outside agency’s compliance policy
FDA approves new DNA-based test to determine blood compatibility
FDA approves new DNA-based test to determine blood compatibility.Test is first of this type approved to report genotypes as final results
Statement from FDA Commissioner Scott Gottlieb, M.D., on new efforts to advance the development of generic copies of complex drugs to improve patient access to medicines
FDA issued a new series of guidance documents that will advance the development of generic transdermal and topical delivery systems
FDA approves expanded use of Gardasil 9 to include individuals 27 through 45 years old
FDA approves expanded use of Gardasil 9 to include individuals 27 through 45 years old
FDA allows marketing of first self-fitting hearing aid controlled by the user
FDA allows marketing of a new device, the Bose Hearing Aid, intended to amplify sounds for individuals 18 years or older with perceived mild to moderate hearing impairment (hearing loss). This is the first hearing aid authorized for marketing by the FDA that enables the user to fit, program and control the hearing aid on his or her own, without assistance from a health care provider.
Statement from FDA Commissioner Scott Gottlieb, M.D., on new agency actions to further deter ‘gaming’ of the generic drug approval process by the use of citizen petitions
FDA issues revised guidance to allow for a more efficient approach to 505(q) petitions and focus more resources on scientific reviews.
Statement from FDA Commissioner Scott Gottlieb, M.D. on FDA’s efforts to strengthen the agency’s medical device cybersecurity program as part of its mission to protect patients
FDA’s efforts to strengthen the agency’s medical device cybersecurity program as part of its mission to protect patients