Aggregatore notizie

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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
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