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
Archive for the ‘Drug Recalls & Safety Notices’ category
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 […]
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
FDA approves a new antibacterial drug to treat a serious lung disease using a novel pathway to spur innovation
The FDA approved the first antibacterial drug under the Limited Population Pathway for Antibacterial and Antifungal Drugs (LPAD). LPAD was created by Congress to spur development of drugs targeting serious infections in limited patient populations with unmet need.
FDA approves first treatment for advanced form of the second most common skin cancer
FDA approves Libtayo (cemiplimab-rwlc) for the treatment of patients with metastatic cutaneous squamous cell carcinoma (CSCC) or locally advanced CSCC who are not candidates for curative surgery or curative radiation. This is the first FDA approval of a drug specifically for advanced CSCC.
FDA authorizes first next generation sequencing-based test to detect very low levels of remaining cancer cells in patients with acute lymphoblastic leukemia or multiple myeloma
FDA authorizes first next generation sequencing-based test to detect very low levels of remaining cancer cells in patients with acute lymphoblastic leukemia or multiple myeloma
Statement by FDA Commissioner Scott Gottlieb, M.D., on preparations for the upcoming flu season and vaccinations
Statement by FDA Commissioner Scott Gottlieb, M.D., on FDA’s role in preparing for flu season
Statement from FDA Commissioner Scott Gottlieb, M.D., on modernizing standards of identity and the use of dairy names for plant-based substitutes
FDA issues a request for information to solicit feedback on how consumers are using plant-based substitutes for milk, cheese and other dairy foods.
Statement from FDA Commissioner Scott Gottlieb, M.D., on new FDA commitment to disclose retailer information for certain food recalls to improve consumer safety
Statement from FDA Commissioner Scott Gottlieb, M.D., on new FDA commitment to disclose retailer information for certain food recalls to improve consumer safety
Remarks from Anna Abram as prepared for delivery to the 2018 Intergovermental Meeting on Drug Compounding
Remarks by FDA’s Anna Abram to the 2018 Intergovermental Meeting on Drug Compounding
FDA awards 12 grants to fund new clinical trials to advance the development of medical products for the treatment of rare diseases
FDA has awarded 12 new clinical trial research grants to enhance the development of medical products for patients with rare diseases
Statement from FDA Commissioner Scott Gottlieb, M.D., on the FDA’s ongoing efforts to prevent foodborne outbreaks of Cyclospora
he safety of the American food supply is one of the U.S. Food and Drug Administration’s highest priorities. A key part of our work in this space focuses on implementing the principles and measures of the FDA Food Safety Modernization Act (FSMA). The actions directed by FSMA are designed to prevent foodborne illness and food […]
FDA takes important steps to encourage appropriate and rational prescribing of opioids through final approval of new safety measures governing the use of immediate-release opioid analgesic medications
FDA takes important steps to encourage appropriate and rational prescribing of opioids through final approval of new safety measures governing the use of immediate-release opioid analgesic medications.
Statement from FDA Commissioner Scott Gottlieb, M.D., on launch of ‘The Real Cost’ Youth E-Cigarette Prevention Campaign amid evidence of sharply rising use among kids
Statement from FDA Commissioner Scott Gottlieb, M.D., on launch of ‘The Real Cost’ Youth E-Cigarette Prevention Campaign amid evidence of sharply rising use among kids.
FDA launches new, comprehensive campaign to warn kids about the dangers of e-cigarette use as part of agency’s Youth Tobacco Prevention Plan, amid evidence of sharply rising use among kids
FDA launched new, comprehensive campaign to warn kids about the dangers of e-cigarette use as part of agency’s Youth Tobacco Prevention Plan, amid evidence of sharply rising use among kids.
FDA approves device for treatment of acute coronary artery perforations
FDA approves device for treatment of acute coronary artery perforations
Statement from Binita Ashar, M.D., of the FDA’s Center for Devices and Radiological Health on agency’s commitment to studying breast implant safety
FDA Statement on agency’s commitment to studying breast implant safety Short Title: FDA Statement on agency’s commitment to studying breast implant safety
FDA provides update on its ongoing investigation into valsartan products; and reports on the finding of an additional impurity identified in one firm’s already recalled products
FDA update on the ongoing investigation into valsartan impurities, recalls and current findings.