FDA issues warning letter to genomics lab for illegally marketing genetic test that claims to predict patients ’ responses to specific medications
(Source: Food and Drug Administration)
Source: Food and Drug Administration - April 4, 2019 Category: American Health Source Type: news
FDA expands approved use of metastatic breast cancer treatment to include male patients
The FDA is extending the indication of Ibrance (palbociclib) capsules in combination with specific endocrine therapies for hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer in male patients. (Source: Food and Drug Administration)
Source: Food and Drug Administration - April 4, 2019 Category: American Health Source Type: news
FDA and CBP bolster collaboration to protect public health and safety
The U.S. Food and Drug Administration and the U.S. Customs and Border Protection (CBP) leaders signed an agreement today to maximize inspection and detection capabilities. (Source: Food and Drug Administration)
Source: Food and Drug Administration - April 4, 2019 Category: American Health Source Type: news
Statement from FDA Commissioner Scott Gottlieb, M.D., and Janet Woodcock, M.D., director of the Center for Drug Evaluation and Research on the agency ’s list of known nitrosamine-free valsartan and ARB class medicines, as part of agency’s ongoing efforts to resolve ongoing safety issue
FDA announces list of nitrosamine-free ARB medications confirmed by the agency to help patients and healthcare providers (Source: Food and Drug Administration)
Source: Food and Drug Administration - April 4, 2019 Category: American Health Source Type: news
Statement from FDA Commissioner Scott Gottlieb, M.D. and Deputy Commissioner Anna Abram on new 2019 efforts to improve the quality of compounded drugs
FDA shares its 2019 compounding priorities as the agency works to improve the quality of compounded drugs (Source: Food and Drug Administration)
Source: Food and Drug Administration - April 3, 2019 Category: American Health Source Type: news
FDA takes new steps to increase access to adverse event report data for medical products used in animals
(Source: Food and Drug Administration)
Source: Food and Drug Administration - April 3, 2019 Category: American Health Source Type: news
Statement by FDA Commissioner Scott Gottlieb, M.D., and Biologics Center Director Peter Marks, M.D., Ph.D. on FDA ’ s continued efforts to stop stem cell clinics and manufacturers from marketing unapproved products that put patients at risk, while progressing the agency ’ s commitment to help advance legitimate stem cell product development under existing agency regulations
FDA statement on stem cell enforcement actions and agency activities to facilitate legitimate product development (Source: Food and Drug Administration)
Source: Food and Drug Administration - April 3, 2019 Category: American Health Source Type: news
Statement from FDA Commissioner Scott Gottlieb, M.D., and Principal Deputy Commissioner Amy Abernethy, M.D., Ph.D., on FDA ’ s ongoing scientific investigation of potential safety issue related to seizures reported following e-cigarette use, particularly in youth and young adults
FDA issues statement on agency ’ s ongoing scientific investigation of potential safety issue related to seizures reported following e-cigarette use, particularly in youth and young adults (Source: Food and Drug Administration)
Source: Food and Drug Administration - April 3, 2019 Category: American Health Source Type: news
Statement from FDA Commissioner Scott Gottlieb, M.D. on steps toward a new, tailored review framework for artificial intelligence-based medical devices
(Source: Food and Drug Administration)
Source: Food and Drug Administration - April 2, 2019 Category: American Health Source Type: news
Wakefern Food Corp. Voluntarily Recalls Wholesome Pantry Organic Nut Butters Because of Possible Health Risk
Wakefern Food Corp. has initiated a voluntary recall of a variety of Wholesome Pantry Organic nut butters because they may be contaminated with Listeria monocytogenes, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Although healthy individuals may suffer only short-term symptoms such as high fever, severe headache, stiffness, nausea, abdominal pain and diarrhea, Listeria infection can cause miscarriages and stillbirths among pregnant women. No illnesses related to the recall have been reported. (Source: Food and Drug Administration)
Source: Food and Drug Administration - April 2, 2019 Category: Food Science Source Type: news
Statement from FDA Commissioner Scott Gottlieb, M.D., on new steps to advance agency ’ s continued evaluation of potential regulatory pathways for cannabis-containing and cannabis-derived products
FDA is announcing a number of important new steps and actions to advance our consideration of a framework for the lawful marketing of appropriate cannabis and cannabis-derived products under our existing authorities. (Source: Food and Drug Administration)
Source: Food and Drug Administration - April 2, 2019 Category: American Health Source Type: news
Statement from FDA Commissioner Scott Gottlieb, M.D., on new steps to advance agency ’s continued evaluation of potential regulatory pathways for cannabis-containing and cannabis-derived products
FDA is announcing a number of important new steps and actions to advance our consideration of a framework for the lawful marketing of appropriate cannabis and cannabis-derived products under our existing authorities. (Source: Food and Drug Administration)
Source: Food and Drug Administration - April 2, 2019 Category: American Health Source Type: news
USDA, EPA, and FDA Recognize April as Winning on Reducing Food Waste Month
The agencies kick off Winning on Reducing Food Waste Month by calling for greater collaboration with public, private, and nonprofit partners as well as state and local officials. (Source: Food and Drug Administration)
Source: Food and Drug Administration - April 2, 2019 Category: American Health Source Type: news
FDA takes new enforcement actions as part of the agency ’ s ongoing effort to combat the illegal online sales of opioids
Agency issued two warning letters to operators of websites that illegally market potentially dangerous, unapproved and misbranded opioid medications. (Source: Food and Drug Administration)
Source: Food and Drug Administration - April 2, 2019 Category: American Health Source Type: news
FDA takes new enforcement actions as part of the agency ’s ongoing effort to combat the illegal online sales of opioids
Agency issued two warning letters to operators of websites that illegally market potentially dangerous, unapproved and misbranded opioid medications. (Source: Food and Drug Administration)
Source: Food and Drug Administration - April 2, 2019 Category: American Health Source Type: news
