Istituzioni

Statement from FDA Commissioner Scott Gottlieb, M.D., on new agency actions to further deter ‘gaming’ of the generic drug approval process by the use of citizen petitions

Food and Drug Administration - Me, 18/09/2019 - 16:26
FDA issues revised guidance to allow for a more efficient approach to 505(q) petitions and focus more resources on scientific reviews.
Categorie: Istituzioni

FDA approves first treatment for patients with rare type of lung disease

Food and Drug Administration - Me, 18/09/2019 - 14:11
FDA approves Ofev (nintedanib) capsules to slow the rate of decline in pulmonary function in adults with interstitial lung disease associated with scleroderma, called SSc-ILD. It is the first FDA-approved treatment for this rare lung condition.
Categorie: Istituzioni

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

Food and Drug Administration - Me, 18/09/2019 - 14:11
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

Food and Drug Administration - Me, 18/09/2019 - 14:11
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

Food and Drug Administration - Me, 18/09/2019 - 14:11
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 clears new indications for existing Lyme disease tests that may help streamline diagnoses

Food and Drug Administration - Me, 18/09/2019 - 14:11
FDA clears new indications for existing Lyme disease tests that may help streamline diagnoses
Categorie: Istituzioni

FDA takes action to protect patients from risk of certain textured breast implants; requests Allergan voluntarily recall certain breast implants and tissue expanders from market

Food and Drug Administration - Me, 18/09/2019 - 14:11
FDA takes action to protect patients from risk of certain textured breast implants; requests Allergan voluntarily recall certain breast implants and tissue expanders from market
Categorie: Istituzioni

FDA suspends facility registration of Texas-based seafood producer after significant, repeated food safety violations

Food and Drug Administration - Me, 18/09/2019 - 14:11
FDA suspends facility registration of Texas-based seafood producer
Categorie: Istituzioni

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

Food and Drug Administration - Me, 18/09/2019 - 14:11
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

FDA takes first action under new international collaboration with Australia and Canada designed to provide a framework for concurrent review of cancer therapies, approving treatment for patients with endometrial carcinoma

Food and Drug Administration - Ma, 17/09/2019 - 16:37
Project Orbis provides a framework for concurrent submission and review of oncology drugs among its international partners. Under this project, the FDA, Australia and Canada collaboratively reviewed applications for two oncology drugs, allowing for simultaneous decisions in all three countries.
Categorie: Istituzioni

Statement alerting patients and health care professionals of NDMA found in samples of ranitidine

Food and Drug Administration - Ve, 13/09/2019 - 21:52
The U.S. Food and Drug Administration has learned that some ranitidine medicines, including some products commonly known as the brand-name drug Zantac, contain a nitrosamine impurity called N-nitrosodimethylamine (NDMA) at low levels.
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

Food and Drug Administration - Me, 11/09/2019 - 06:37
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 warns company for putting consumers at risk with drug manufacturing data integrity violations

Food and Drug Administration - Me, 11/09/2019 - 06:37
The FDA posted a warning letter for significant current good manufacturing practice violations, including data integrity issues.
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

Food and Drug Administration - Me, 11/09/2019 - 06:36
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 new antibiotic to treat community-acquired bacterial pneumonia

Food and Drug Administration - Me, 11/09/2019 - 06:36
The FDA approved Xenleta (lefamulin) to treat adults with community-acquired bacterial pneumonia.
Categorie: Istituzioni

Statement on data accuracy issues with recently approved gene therapy

Food and Drug Administration - Me, 11/09/2019 - 06:36
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 approves new drug for treatment-resistant forms of tuberculosis that affects the lungs

Food and Drug Administration - Me, 11/09/2019 - 06:36
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

Federal judge enters consent decree against Arkansas food and medical product grocery warehouse for insanitary conditions

Food and Drug Administration - Me, 11/09/2019 - 06:36
A federal court ordered an Arkansas company to stop distributing food, drug products, medical devices and cosmetics until the company complies with the Federal Food, Drug, and Cosmetic Act (FD&C Act) and other requirements listed in a consent decree.
Categorie: Istituzioni

FDA warns company marketing unapproved cannabidiol products with unsubstantiated claims to treat cancer, Alzheimer’s disease, opioid withdrawal, pain and pet anxiety

Food and Drug Administration - Me, 11/09/2019 - 06:36
FDA has issued a warning letter to Curaleaf Inc. for illegally selling unapproved cannabidiol products online with unsubstantiated claims that the products treat cancer, Alzheimer’s disease, opioid withdrawal, pain and pet anxiety, among other conditions or diseases.
Categorie: Istituzioni

FDA approves first therapy for rare joint tumor

Food and Drug Administration - Me, 11/09/2019 - 06:35
FDA approves first therapy for treatment of adult patients with symptomatic tenosynovial giant cell tumor (TGCT)
Categorie: Istituzioni
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