FDA agrees to expedited review of Eli Lilly and Co’s diabetes drug Mounjaro to treat obesity, months after a study showed it helped people lose more than 20% of their weight. The FDA had approved Mounjaro for the treatment of Type 2 diabetes in May. The drug, also known as Tirzepatide, is expected to become a blockbuster treatment if approved for obesity.
Obesity continues to be a major health concern in the United States, with the disease estimated to have affected more than 40% of the population and cost nearly $173 billion annually.
Domestic and foreign companies need to stop importing or exporting non-NIOSH-approved respirators. FDA revoked Emergency Use Authorizations (EUAs) of all non-NIOSH (National Institute of Occupational Safety and Health)-approved disposable respirators.
Canada and the U.S. have a Food Safety Systems Recognition Arrangement (FSSRA). The Foreign Supplier Verification Program (FSVP) provides modified requirements to U.S. importers of food covered under the FSSRA from manufacturers in good regulatory standing with the Canadian Food Inspection Agency (CFIA).
Radiation therapy is sometimes combined with hormone therapy (also called androgen deprivation therapy or ADT). Androgens such as testosterone are hormones that can cause prostate cancer cells to grow. ADT stops testosterone from being produced or directly blocks it from acting on prostate cancer cells. Hormone therapy may be given to patients with prostate cancer that has recurred after radiation or surgery and is the standard of care for men with cancer that has spread outside the prostate to other areas of the body (metastatic disease).
Antibiotics like amoxicillin treat many different infections caused by bacteria, but they are not effective against viral infections like the common cold, most sore throats, and the flu.
FDA posted warning letters to five companies for illegally selling products containing cannabidiol (CBD). These companies are selling CBD containing products that people may confuse for traditional foods, or beverages which may result in unintentional consumption or overconsumption of CBD.
Don’t take a chance assuming that regulations in the United States, Canada, Mexico, Brazil, Australia, India, South Korea, China, Japan, Russia, European Union, are the same or similar.
BIENNIAL RENEWAL OF 2022
La registrazione FDA è un prerequisito per esportare cibo negli Stati Uniti. Sono 10.707 le aziende alimentari italiane iscritte alla FDA statunitense.
El registro ante la FDA es un requisito previo para exportar alimentos a los Estados Unidos. Hay 4.873 empresas alimentarias españolas, así como 6.571 empresas mexicanas de alimentos, registradas ante la FDA estadounidense.