Istituzioni

Statement on measuring the progress being made through implementing the FDA Food Safety Modernization Act

Food and Drug Administration - Lu, 30/09/2019 - 18:41
New performance measures show progress being made in implementing the Food Safety Modernization Act
Categorie: Istituzioni

FDA and DEA warn website operators illegally selling opioids

Food and Drug Administration - Lu, 30/09/2019 - 16:05
FDA and DEA issued joint warning letters to online networks illegally marketing unapproved and misbranded versions of opioids that are potentially dangerous.
Categorie: Istituzioni

Statement on continued efforts to evaluate materials in medical devices to address potential safety questions

Food and Drug Administration - Lu, 30/09/2019 - 14:42
FDA announces next steps the agency is taking as part of its ongoing work to better evaluate the safety of specific materials used in medical devices. This includes holding our first public advisory committee meeting to convene experts and the public on this issue and providing new information on sc
Categorie: Istituzioni

FDA approves first treatment for children with rare diseases that cause inflammation of small blood vessels

Food and Drug Administration - Ve, 27/09/2019 - 18:39
FDA approves Rituxan (rituximab) injection to treat granulomatosis with polyangiitis (GPA) and microscopic polyangiitis (MPA) in children ages 2 and older in combination with steroid hormones. It is the first approved treatment for children with these rare vasculitis diseases.
Categorie: Istituzioni

FDA approves treatment for adults and children with all genotypes of hepatitis C and compensated cirrhosis that shortens duration of treatment to eight weeks

Food and Drug Administration - Gi, 26/09/2019 - 20:35
FDA expands approval of Mavyret (glecaprevir and pibrentasvir) tablets for an eight-week duration for the treatment of adults and children with hepatitis C virus genotype 1, 2, 3, 4, 5 or 6 infection and compensated cirrhosis and have not been previously treated for HCV (treatment-naïve).
Categorie: Istituzioni

Statement on new steps to advance digital health policies that encourage innovation and enable efficient and modern regulatory oversight

Food and Drug Administration - Gi, 26/09/2019 - 14:21
Statement from FDA Principal Deputy Commissioner Amy Abernethy, M.D., Ph.D., on new steps to advance digital health policies that encourage innovation and enable efficient and modern regulatory oversight
Categorie: Istituzioni

Remarks prepared for testimony before a U.S. House Energy and Commerce Subcommittee on FDA Regulation of Electronic Nicotine Delivery Systems and Investigation of Vaping Illnesses

Food and Drug Administration - Me, 25/09/2019 - 18:05
Remarks from Acting FDA Commissioner Ned Sharpless, M.D. as prepared for testimony before a U.S. House Energy and Commerce Subcommittee on FDA Regulation of Electronic Nicotine Delivery Systems and Investigation of Vaping Illnesses
Categorie: Istituzioni

FDA approves first live, non-replicating vaccine to prevent smallpox and monkeypox

Food and Drug Administration - Ma, 24/09/2019 - 20:15
The U.S. Food and Drug Administration announced today the approval of Jynneos Smallpox and Monkeypox Vaccine, Live, Non-Replicating, for the prevention of smallpox and monkeypox disease in adults 18 years of age and older determined to be at high risk for smallpox or monkeypox infection. This is the
Categorie: Istituzioni

Statement on FDA efforts to encourage patient engagement in medical device clinical investigations

Food and Drug Administration - Lu, 23/09/2019 - 15:38
FDA releases draft guidance providing our proposed recommendations for manufacturers to engage patients in multiple aspects of medical device clinical investigation design
Categorie: Istituzioni

Statement on final guidance to help advance development of novel treatments for ALS

Food and Drug Administration - Lu, 23/09/2019 - 15:10
Statement on final guidance to help advance development of novel treatments for ALS
Categorie: Istituzioni

Statement on continued efforts to increase availability of all forms of naloxone to help reduce opioid overdose deaths

Food and Drug Administration - Ve, 20/09/2019 - 16:46
Statement on continued efforts to increase availability of all forms of naloxone to help reduce opioid overdose deaths
Categorie: Istituzioni

FDA approves first oral GLP-1 treatment for type 2 diabetes

Food and Drug Administration - Ve, 20/09/2019 - 15:18
FDA approves Rybelsus (semaglutide) oral tablets to improve blood sugar in adults with type 2 diabetes, with diet and exercise. It is first GLP-1 receptor protein treatment approved in U.S.
Categorie: Istituzioni

FDA issues proposed rule for premarket tobacco product applications as part of commitment to continuing strong oversight of e-cigarettes and other tobacco products

Food and Drug Administration - Ve, 20/09/2019 - 15:07
FDA issues proposed rule for premarket tobacco product applications as part of commitment to continuing strong oversight of e-cigarettes and other tobacco products
Categorie: Istituzioni

FDA recommends health care facilities and manufacturers begin transitioning to duodenoscopes with disposable components to reduce risk of patient infection

Food and Drug Administration - Ve, 20/09/2019 - 14:36
FDA recommends duodenoscope manufacturers and health care facilities transition to different types of duodenoscopes that may pose less risk to patient safety.
Categorie: Istituzioni

Statement from FDA Commissioner Scott Gottlieb, M.D., on agency’s ongoing commitment to improving efficiency, transparency of tobacco product application review process as part of FDA’s comprehensive framework to reduce tobacco-related disease and death

Food and Drug Administration - Ve, 20/09/2019 - 03:01
Statement from FDA Commissioner Scott Gottlieb, M.D., on agency’s ongoing commitment to improving efficiency, transparency of tobacco product application review process as part of FDA’s comprehensive framework to reduce tobacco-related disease and death.
Categorie: Istituzioni

FDA continues to take steps to fulfill its commitment to strengthen and modernize the 510(k) medical device program

Food and Drug Administration - Gi, 19/09/2019 - 16:13
FDA is issuing draft guidances outlining recommended premarket performance criteria and testing methodologies for four specific types of devices under the Safety and Performance Based Pathway for medical devices.
Categorie: Istituzioni

FDA sends warning to company for selling unapproved umbilical cord blood and umbilical cord products that may put patients at risk; continues to warn patients of the risk of unapproved stem cell therapy

Food and Drug Administration - Gi, 19/09/2019 - 14:29
: FDA sends warning to company for selling unapproved umbilical cord blood and umbilical cord products that may put patients at risk; continues to warn patients of the risk of unapproved stem cell therapy
Categorie: Istituzioni

Statement on federal and state collaboration to investigate respiratory illnesses reported after use of e-cigarette products

Food and Drug Administration - Gi, 19/09/2019 - 14:29
FDA and CDC are providing updates about federal and state efforts to investigate respiratory illnesses reported after the use of e-cigarette products.
Categorie: Istituzioni

Statement on the agency’s ongoing efforts to resolve safety issue with ARB medications

Food and Drug Administration - Gi, 19/09/2019 - 14:29
The FDA is issuing an update regarding the ongoing efforts to resolve safety issues with ARB medications.
Categorie: Istituzioni

Trump Administration Combating Epidemic of Youth E-Cigarette Use with Plan to Clear Market of Unauthorized, Non-Tobacco-Flavored E-Cigarette Products

Food and Drug Administration - Me, 18/09/2019 - 20:51
: FDA intends to finalize compliance policy that would prioritize enforcement of premarket authorization requirements for non-tobacco-flavored e-cigarettes, clearing the market these products.
Categorie: Istituzioni
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