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

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 approves new treatment for complicated urinary tract and complicated intra-abdominal infections

FDA approved Recarbrio, an antibacterial drug to treat adults with complicated urinary tract infections (cUTI) and complicated intra-abdominal infections (cIAI).
Categorie: Istituzioni

Statement on the agency’s actions to tackle the epidemic of youth vaping and court ruling on application submission deadlines for certain tobacco products, including e-cigarettes

FDA issues statement on actions to tackle youth vaping epidemic and court ruling on application deadlines for certain tobacco products, including e-cigarettes
Categorie: Istituzioni

FDA approves new treatment for refractory multiple myeloma

FDA grants accelerated approval to Xpovio (selinexor) tablets in combination with the corticosteroid dexamethasone for the treatment of adult patients with relapsed refractory multiple myeloma (RRMM) who have received at least four prior therapies and whose disease is resistant to several other form
Categorie: Istituzioni

FDA warns repackers distributing pharmaceutical ingredients, including opioids, for putting consumers at risk with significant violations of manufacturing quality standards

FDA has issued warning letters to three repackers of active pharmaceutical ingredients (API) for significant violations of current good manufacturing practice (CGMP) requirements
Categorie: Istituzioni

Statement on steps to make health care professional and patient labeling information for prescription medications consistent and clear

FDA is issuing two new draft guidances on drug labeling, Drug Abuse and Dependence Section of Labeling for Human Prescription Drug and Biological Products - Content and Format and Instructions for Use — Patient Labeling for Human Prescription Drug and Biological Products and Drug-Device and Biologic
Categorie: Istituzioni

FDA warns patients and health care providers about potential cybersecurity concerns with certain Medtronic insulin pumps

FDA warns patients and providers that certain Medtronic MiniMed insulin pumps are recalled due to potential cybersecurity risks and recommends patients switch to models better equipped to protect against these potential risks.
Categorie: Istituzioni

FDA approves first treatment for neuromyelitis optica spectrum disorder, a rare autoimmune disease of the central nervous system

FDA approves Soliris (eculizumab) injection for intravenous use for the treatment of neuromyelitis optica spectrum disorder (NMOSD) in adult patients who are anti-aquaporin-4 (AQP4) antibody positive.
Categorie: Istituzioni

FDA issues third status report on investigation into potential connection between certain diets and cases of canine heart disease

This press release highlights an update on the FDA’s investigation into a potential connection between certain diets and cases of canine heart disease
Categorie: Istituzioni

FDA approves first treatment for chronic rhinosinusitis with nasal polyps

FDA approves Dupixent to treat adults with nasal polyps accompanied by chronic rhinosinusitis or prolonged inflammation of the sinuses and nasal cavity.
Categorie: Istituzioni

Statement on stem cell clinic permanent injunction and FDA’s ongoing efforts to protect patients from risks of unapproved products

Statement by Acting FDA Commissioner Ned Sharpless, M.D., and Biologics Center Director Peter Marks, M.D., Ph.D. on stem cell clinic permanent injunction and FDA’s ongoing efforts to protect patients from risks of unapproved products
Categorie: Istituzioni

FDA issues warnings to companies selling illegal, unapproved kratom drug products marketed for opioid cessation, pain treatment and other medical uses

FDA issued warning letters to two marketers and distributors of kratom products – Cali Botanicals and Kratom NC– for illegally selling unapproved, misbranded kratom-containing drug products with unproven claims about their ability to treat or cure opioid addiction and withdrawal symptoms.
Categorie: Istituzioni

FDA approves new treatment for hypoactive sexual desire disorder in premenopausal women

FDA approved Vyleesi (bremelanotide) to treat acquired, generalized hypoactive sexual desire disorder (HSDD) in premenopausal women.
Categorie: Istituzioni

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

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

Statement on agency’s efforts to increase transparency in medical device reporting

The FDA is taking a number of important steps to update its Medical Device Reporting Program.
Categorie: Istituzioni

Statement on the FDA’s benefit-risk framework for evaluating opioid analgesics

FDA issues a new draft guidance on the application of the benefit-risk assessment framework for evaluating applications for opioids.
Categorie: Istituzioni

Statement on a new effort to improve transparency and predictability for generic drug applicants to help increase timely access to high-quality, lower cost generic drugs

FDA is enhancing one of the agency’s most viewed databases for industry, the Paragraph IV Patent Certifications List, which provides information about exclusivity related to generic challenges of patents on “brand” drug products (180-day exclusivity).
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

FDA launches public education campaign to encourage safe removal of unused opioid pain medicines from homes

“Remove the Risk” to raise awareness about proper disposal of prescription opioids
Categorie: Istituzioni
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