FDA approved first cellular therapy, Amtagvi, to treat patients with unresectable or metastatic skin cancer melanoma.
A portion of the patient’s tumor tissue is removed during a surgical procedure prior to treatment. The patients’ T cells are separated from the tumor tissue, further manufactured and then returned to the same patient as a single dose for infusion.
Medical Tourism: Treatments, Markets and Health System Implications.
A growing trade in healthcare has involved the movement of patients across borders in the pursuit of medical treatment and health, a phenomenon commonly termed “medical tourism”.
Anti-abortion group’s lawsuit alleges that the FDA’s approval for medication abortion drugs (mifepristone and misoprostol) from Danco Laboratories LLC, was unlawful and should be revoked.
Temporary enforcement discretion for pending Unique Facility Identifiers (UFI) is no longer available. The option to select the “Pending UFI Option” for Food Facility Registrations has been terminated.
As a result, FDA will not confirm your registration or provide you with a registration number until FDA verifies the accuracy of your facility’s UFI and verifies that the facility-specific address associated with the UFI is the same address associated with your registration.
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).
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.
The U.S. Food and Drug Administration has approved a novel treatment for advanced melanoma, the most deadly form of skin cancer.
Amtagvi, made by Iovance Biotherapeutics Inc, becomes the first cellular therapy approved to treat this form of solid tumor cancer.
The Food and Drug Administration approved the first vaccine for pregnant women to protect their babies against respiratory syncytial virus during their first six months.
3M Co has tentatively agreed to pay more than $5.5 billion to resolve over 300,000 lawsuits claiming it sold the U.S. military defective combat earplugs (regulated as medical devices by the FDA).
FOREIGN SUPPLIER VERIFICATION PROGRAM (FSVP)
La registrazione FDA è un prerequisito per esportare cibo negli Stati Uniti. Sono 10.026 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 4.611 empresas alimentarias españolas, así como 7.552 empresas mexicanas de alimentos, registradas ante la FDA estadounidense.