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.
Category Archives: Drug Safety Information Podcasts
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 safety problems from happening.
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.