FDA issues revised guidance to allow for a more efficient approach to 505(q) petitions and focus more resources on scientific reviews.
FDA’s efforts to strengthen the agency’s medical device cybersecurity program as part of its mission to protect patients
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 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
Statement by FDA Commissioner Scott Gottlieb, M.D., on FDA’s role in preparing for flu season
FDA issues a request for information to solicit feedback on how consumers are using plant-based substitutes for milk, cheese and other dairy foods.
Mauna Loa Macadamia Nut Corporation is voluntarily recalling all of its products produced at the Keaau facility between Sept. 6 – 21, 2018 due to a potential contamination of Escherichia coli (E. coli). The recall was initiated due to E. coli being detected in the well water and distribution system that supplies the firm’s operations. […]
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 by FDA’s Anna Abram to the 2018 Intergovermental Meeting on Drug Compounding
FDA has awarded 12 new clinical trial research grants to enhance the development of medical products for patients with rare diseases
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.
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 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 Statement on agency’s commitment to studying breast implant safety Short Title: FDA Statement on agency’s commitment to studying breast implant safety
FDA update on the ongoing investigation into valsartan impurities, recalls and current findings.
FDA approves Lumoxiti (moxetumomab pasudotox-tdfk) for the treatment of adult patients with relapsed or refractory hairy cell leukemia