Food and Drug Administration

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

Dom, 15/09/2019 - 21:19
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

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

Dom, 15/09/2019 - 21:19
: 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

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

Dom, 15/09/2019 - 21:19
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 recommends health care facilities and manufacturers begin transitioning to duodenoscopes with disposable components to reduce risk of patient infection

Dom, 15/09/2019 - 21:19
FDA recommends duodenoscope manufacturers and health care facilities transition to different types of duodenoscopes that may pose less risk to patient safety.
Categorie: Istituzioni

FDA approves new add-on drug to treat off episodes in adults with Parkinson’s disease

Dom, 15/09/2019 - 21:19
FDA approves new add-on drug to treat off episodes in adults with Parkinson’s disease
Categorie: Istituzioni

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

Dom, 15/09/2019 - 21:19
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

Dom, 15/09/2019 - 21:19
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

Dom, 15/09/2019 - 21:19
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 expands indication for several transcatheter heart valves to patients at low risk for death or major complications associated with open-heart surgery

Dom, 15/09/2019 - 21:19
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

Dom, 15/09/2019 - 21:19
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

Dom, 15/09/2019 - 21:19
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

Dom, 15/09/2019 - 21:19
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 approves new drug for treatment-resistant forms of tuberculosis that affects the lungs

Dom, 15/09/2019 - 21:19
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

Statement on data accuracy issues with recently approved gene therapy

Dom, 15/09/2019 - 21:19
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 clears new indications for existing Lyme disease tests that may help streamline diagnoses

Dom, 15/09/2019 - 21:19
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

Dom, 15/09/2019 - 21:19
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

Dom, 15/09/2019 - 21:19
FDA suspends facility registration of Texas-based seafood producer
Categorie: Istituzioni

FDA launches its first youth e-cigarette prevention TV ads, plans new educational resources as agency approaches one-year anniversary of public education campaign

Dom, 15/09/2019 - 21:19
FDA is launching its first youth e-cigarette prevention TV ads and is planning to provide new educational resources as agency approaches one-year anniversary of public education campaign.
Categorie: Istituzioni

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

Dom, 15/09/2019 - 21:19
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 expands approval of treatment for cystic fibrosis to include patients ages 6 and older

Dom, 15/09/2019 - 21:19
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