Istituzioni

FDA approves first treatment for neuromyelitis optica spectrum disorder, a rare autoimmune disease of the central nervous system

Food and Drug Administration - Ve, 02/08/2019 - 17:21
FDA approves Soliris (eculizumab) injection for intravenous use for the treatment of neuromyelitis optica spectrum disorder (NMOSD) in adult patients who are anti-aquaporin-4 (AQP4) antibody positive.
Categorie: Istituzioni

FDA issues third status report on investigation into potential connection between certain diets and cases of canine heart disease

Food and Drug Administration - Ve, 02/08/2019 - 17:21
This press release highlights an update on the FDA’s investigation into a potential connection between certain diets and cases of canine heart disease
Categorie: Istituzioni

FDA approves first treatment for chronic rhinosinusitis with nasal polyps

Food and Drug Administration - Ve, 02/08/2019 - 17:21
FDA approves Dupixent to treat adults with nasal polyps accompanied by chronic rhinosinusitis or prolonged inflammation of the sinuses and nasal cavity.
Categorie: Istituzioni

Statement on stem cell clinic permanent injunction and FDA’s ongoing efforts to protect patients from risks of unapproved products

Food and Drug Administration - Ve, 02/08/2019 - 17:21
Statement by Acting FDA Commissioner Ned Sharpless, M.D., and Biologics Center Director Peter Marks, M.D., Ph.D. on stem cell clinic permanent injunction and FDA’s ongoing efforts to protect patients from risks of unapproved products
Categorie: Istituzioni

FDA issues warnings to companies selling illegal, unapproved kratom drug products marketed for opioid cessation, pain treatment and other medical uses

Food and Drug Administration - Lu, 29/07/2019 - 15:11
FDA issued warning letters to two marketers and distributors of kratom products – Cali Botanicals and Kratom NC– for illegally selling unapproved, misbranded kratom-containing drug products with unproven claims about their ability to treat or cure opioid addiction and withdrawal symptoms.
Categorie: Istituzioni

FDA approves new treatment for hypoactive sexual desire disorder in premenopausal women

Food and Drug Administration - Me, 24/07/2019 - 12:27
FDA approved Vyleesi (bremelanotide) to treat acquired, generalized hypoactive sexual desire disorder (HSDD) in premenopausal women.
Categorie: Istituzioni

FDA expands approval of treatment for cystic fibrosis to include patients ages 6 and older

Food and Drug Administration - Me, 24/07/2019 - 12:27
FDA expanded the indication for Symdeko for treatment of pediatric patients ages 6 years and older with cystic fibrosis who have certain genetic mutations.
Categorie: Istituzioni

Statement on agency’s efforts to increase transparency in medical device reporting

Food and Drug Administration - Ma, 23/07/2019 - 11:53
The FDA is taking a number of important steps to update its Medical Device Reporting Program.
Categorie: Istituzioni

Statement on the FDA’s benefit-risk framework for evaluating opioid analgesics

Food and Drug Administration - Lu, 22/07/2019 - 11:25
FDA issues a new draft guidance on the application of the benefit-risk assessment framework for evaluating applications for opioids.
Categorie: Istituzioni

Statement on a new effort to improve transparency and predictability for generic drug applicants to help increase timely access to high-quality, lower cost generic drugs

Food and Drug Administration - Lu, 22/07/2019 - 11:25
FDA is enhancing one of the agency’s most viewed databases for industry, the Paragraph IV Patent Certifications List, which provides information about exclusivity related to generic challenges of patents on “brand” drug products (180-day exclusivity).
Categorie: Istituzioni

FDA approves new treatment for pediatric patients with type 2 diabetes

Food and Drug Administration - Gi, 18/07/2019 - 09:42
: FDA approves Victoza (liraglutide) injection for pediatric patients with type 2 diabetes. Victoza creates the same effect as GLP-1 receptor protein and is the first non-insulin drug approved since metformin in 2000.
Categorie: Istituzioni

FDA Statement on the FDA’s ongoing investigation into valsartan and ARB class impurities and the agency’s steps to address the root causes of the safety issues

Food and Drug Administration - Gi, 18/07/2019 - 09:42
FDA describes the ongoing investigation into the ARB class impurities and agency’s steps to address the root causes of the safety issues
Categorie: Istituzioni

Federal officials seize adulterated dietary supplements from Life Rising Corporation due to poor manufacturing practices

Food and Drug Administration - Me, 17/07/2019 - 09:18
Federal officials seize adulterated dietary supplements from Life Rising Corporation due to poor manufacturing practices
Categorie: Istituzioni

Statement on FDA’s scientific work to understand per- and polyfluoroalkyl substances (PFAS) in food, and findings from recent FDA surveys

Food and Drug Administration - Lu, 15/07/2019 - 08:25
FDA’s scientific work to understand per- and polyfluoroalkyl substances (PFAS) in food, and findings from recent FDA surveys
Categorie: Istituzioni

FDA finalizes guidance for premarket tobacco product applications for electronic nicotine delivery systems as part of commitment to continuing a strong oversight of e-cigarettes

Food and Drug Administration - Me, 03/07/2019 - 01:42
FDA finalizes guidance for manufacturers submitting premarket tobacco product applications for electronic nicotine delivery systems, such as e-cigarettes or “vapes.”
Categorie: Istituzioni

FDA approves first chemoimmunotherapy regimen for patients with relapsed or refractory diffuse large B-cell lymphoma

Food and Drug Administration - Ma, 02/07/2019 - 01:05
FDA approved Polivy in combination with the chemotherapy bendamustine and a rituximab product to treat adult patients with diffuse large B-cell lymphoma that has progressed or returned after at least two prior therapies.
Categorie: Istituzioni

FDA permits marketing of first medical device for relief of pain associated with irritable bowel syndrome in patients 11-18 years of age

Food and Drug Administration - Lu, 01/07/2019 - 00:33
FDA permits marketing of the first medical device to aid in the reduction of functional abdominal pain in patients 11-18 years of age with irritable bowel syndrome (IBS) when combined with other therapies for IBS.
Categorie: Istituzioni

Remarks on World Food Safety Day: ‘Food Safety Is Everyone’s Business’

Food and Drug Administration - Me, 26/06/2019 - 22:41
Remarks from Deputy Commissioner Frank Yiannas on World Food Safety Day
Categorie: Istituzioni

FDA, FTC take action to protect kids by citing four firms that make, sell flavored e-liquids for violations related to online posts by social media influencers on their behalf

Food and Drug Administration - Me, 26/06/2019 - 22:41
FDA and FTC cite four firms that make or sell several flavored e-liquid products for violations related to online posts by social media influencers on each company’s behalf.
Categorie: Istituzioni
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