Food and Drug Administration

FDA warns company for putting consumers at risk with drug manufacturing data integrity violations

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The FDA posted a warning letter for significant current good manufacturing practice violations, including data integrity issues.
Categorie: Istituzioni

Statement on new results demonstrating continued success of the agency’s youth smoking prevention efforts and significant public health cost savings

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A new study in the American Journal of Preventive Medicine highlights the continued success and impact the FDA’s “The Real Cost” campaign has had on youth smoking initiation.
Categorie: Istituzioni

FDA approves new antibiotic to treat community-acquired bacterial pneumonia

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The FDA approved Xenleta (lefamulin) to treat adults with community-acquired bacterial pneumonia.
Categorie: Istituzioni

FDA warns consumers about the dangerous and potentially life threatening side effects of Miracle Mineral Solution

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The FDA is warning consumers not to purchase or drink Miracle Mineral Solution, a product sold online as a medical treatment due to a recent rise in reported health issues.
Categorie: Istituzioni

FDA approves new device to improve symptoms in patients with advanced heart failure

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FDA approves new device to improve symptoms in patients with advanced heart failure
Categorie: Istituzioni

FDA expands indication for several transcatheter heart valves to patients at low risk for death or major complications associated with open-heart surgery

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FDA expands indication for several transcatheter heart valves to patients at low risk for death or major complications associated with open-heart surgery.
Categorie: Istituzioni

FDA approves first of its kind device to treat pediatric patients with progressive idiopathic scoliosis

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FDA approves first of its kind device to treat pediatric patients with progressive idiopathic scoliosis
Categorie: Istituzioni

FDA approves treatment for patients with rare bone marrow disorder

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FDA approves treatment for adult patients with certain types of myelofibrosis.
Categorie: Istituzioni

FDA approves third oncology drug that targets a key genetic driver of cancer, rather than a specific type of tumor

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FDA approves third cancer treatment based on a common biomarker across different types of tumors rather than the location in the body where the tumor originated
Categorie: Istituzioni

FDA proposes new required health warnings with color images for cigarette packages and advertisements to promote greater public understanding of negative health consequences of smoking

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FDA has issued a proposed rule to require new health warnings on cigarette packages and in ads to promote greater public understanding of the negative health consequences of smoking.
Categorie: Istituzioni

FDA approves new drug for treatment-resistant forms of tuberculosis that affects the lungs

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FDA approved Pretomanid Tablets in combination with bedaquiline and linezolid for the treatment of a specific type of highly treatment-resistant tuberculosis of the lungs.
Categorie: Istituzioni

FDA sends warning to company for marketing dangerous unapproved stem cell products that put patients at risk and puts other stem cell firms, providers on notice

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FDA sends warning letter to Genetech, Inc. and letters to other companies to reiterate the FDA’s compliance and enforcement policy regarding stem cells.
Categorie: Istituzioni

FDA notifies four companies to remove 44 flavored e-liquid and hookah tobacco products from the market for not having required marketing authorization

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FDA has notified four firms that 44 flavored e-liquid and hookah tobacco products do not have the required marketing authorization, and thus cannot be legally sold in the U.S.
Categorie: Istituzioni

Statement on data accuracy issues with recently approved gene therapy

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Statement by Peter Marks, M.D., Ph.D., director of FDA’s Center for Biologics Evaluation and Research, on data accuracy issues with recently approved gene therapy
Categorie: Istituzioni

FDA statement on court ruling related to compounded bulk drug substances and the agency’s ongoing efforts to implement its compounding authorities

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A U.S. District Court judge in Washington, D.C. issued a decision that upheld FDA’s interpretation of clinical need regarding the bulk substances that may be used by outsourcing facilities in drug compounding.
Categorie: Istituzioni

FDA approves first therapy for rare joint tumor

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FDA approves first therapy for treatment of adult patients with symptomatic tenosynovial giant cell tumor (TGCT)
Categorie: Istituzioni

Statement from FDA Commissioner Scott Gottlieb, M.D., in response to GAO report regarding FDA’s ongoing commitment to employing a least burdensome approach to device review

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Statement from FDA Commissioner Scott Gottlieb, M.D., in response to GAO report regarding FDA’s ongoing commitment to employing a least burdensome approach to device review
Categorie: Istituzioni

Statement from FDA Commissioner Scott Gottlieb, M.D., on a key step in advancing FDA’s oversight of drug compounding and implementing new laws governing outsourcing facilities

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Statement from FDA Commissioner Scott Gottlieb, M.D., on a key step in advancing FDA’s oversight of drug compounding and implementing new laws governing outsourcing facilities
Categorie: Istituzioni

FDA announces comprehensive regenerative medicine policy framework

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FDA announces comprehensive regenerative medicine policy framework to spur innovation, efficient access to potentially transformative products, while ensuring safety and efficacy.
Categorie: Istituzioni

Statement on new guidance for the declaration of added sugars on food labels for single-ingredient sugars and syrups and certain cranberry products

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This is a statement regarding the FDA’s new guidance for the declaration of added sugars on food labels for single-ingredient sugars and syrups and certain cranberry products.
Categorie: Istituzioni