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

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 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

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

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

: 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

Statement on improving adverse event reporting of compounded drugs to protect patients

The FDA is working to improve adverse event reporting of compounded drugs to protect patients
Categorie: Istituzioni

FDA warns JUUL Labs for marketing unauthorized modified risk tobacco products, including in outreach to youth

FDA warns JUUL Labs for marketing unauthorized modified risk tobacco products, including in outreach to youth
Categorie: Istituzioni

FDA sends warning to company for selling unapproved umbilical cord blood and umbilical cord products that may put patients at risk; continues to warn patients of the risk of unapproved stem cell therapy

: FDA sends warning to company for selling unapproved umbilical cord blood and umbilical cord products that may put patients at risk; continues to warn patients of the risk of unapproved stem cell therapy
Categorie: Istituzioni

Statement on federal and state collaboration to investigate respiratory illnesses reported after use of e-cigarette products

FDA and CDC are providing updates about federal and state efforts to investigate respiratory illnesses reported after the use of e-cigarette products.
Categorie: Istituzioni

Statement on the agency’s ongoing efforts to resolve safety issue with ARB medications

The FDA is issuing an update regarding the ongoing efforts to resolve safety issues with ARB medications.
Categorie: Istituzioni

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 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 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 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

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

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

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
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