Istituzioni
Coronavirus (COVID-19) Update: FDA Authorizes First COVID-19 Test Available without a Prescription That Also Detects Flu and RSV
Today, FDA authorized the Labcorp Seasonal Respiratory Virus RT-PCR DTC Test, the first direct-to-consumer (non-prescription) multi-analyte COVID-19 test authorized by FDA.
Categorie: Istituzioni
FDA Roundup: May 13, 2022
The U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency.
Categorie: Istituzioni
FDA Approves Novel, Dual-Targeted Treatment for Type 2 Diabetes
The FDA approved a new treatment to improve blood sugar control in adults with type 2 diabetes, as an addition to diet and exercise.
Categorie: Istituzioni
FDA Roundup: May 10, 2022
The U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency.
Categorie: Istituzioni
FDA Takes Important Steps to Improve Supply of Infant and Specialty Formula Products
The FDA is providing an update on its work to increase the availability of infant and specialty formula products.
Categorie: Istituzioni
FDA Roundup: May 6, 2022
The U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency.
Categorie: Istituzioni
Coronavirus (COVID-19) Update: FDA Limits Use of Janssen COVID-19 Vaccine to Certain Individuals
The FDA has limited the authorized use of the Janssen COVID-19 Vaccine to individuals 18 older for whom other available COVID-19 vaccines are not accessible or clinically appropriate, and to individuals 18 and older who elect to receive it because they would otherwise not receive a COVID-19 vaccine.
Categorie: Istituzioni
FDA Permits Marketing for New Test to Improve Diagnosis of Alzheimer’s Disease
FDA today permitted marketing for the first in vitro diagnostic test for early detection of amyloid plaques associated with Alzheimer’s disease.
Categorie: Istituzioni
FDA Issues Warning Letters to Companies Illegally Selling CBD and Delta-8 THC Products
The FDA issued warning letters to five companies for selling products labeled as containing delta-8 THC in ways that violate the FD&C Act. This action is the first time the FDA has issued warning letters for products containing delta-8 THC.
Categorie: Istituzioni
FDA Roundup: May 3, 2022
The U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency.
Categorie: Istituzioni
FDA Roundup: April 29, 2022
The U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency.
Categorie: Istituzioni
Coronavirus (COVID-19) Update: FDA Announces Tentative Advisory Committee Meeting Schedule Regarding COVID- 19 Vaccines
The FDA plans to hold virtual meetings of its Vaccines and Related Biological Products Advisory Committee (VRBPAC) in anticipation of potential submissions of emergency use authorization (EUA) requests in the coming months that have been publicly announced by COVID-19 vaccine manufacturers.
Categorie: Istituzioni
La FDA propone normas que prohíben los cigarrillos mentolados y puros saborizados para prevenir la iniciación al tabaquismo en adolescentes y reducir significativamente la morbilidad y mortalidad relacionadas con el uso del tabaco
La FDA ha propuesto normas para productos de tabaco que prohíben el mentol en los cigarrillos y todos los sabores en los puros.
Categorie: Istituzioni
FDA Proposes Rules Prohibiting Menthol Cigarettes and Flavored Cigars to Prevent Youth Initiation, Significantly Reduce Tobacco-Related Disease and Death
FDA proposed product standards to prohibit menthol in cigarettes and all flavors in cigars.
Categorie: Istituzioni
FDA Takes Steps to Limit Lead in Juice to Further Reduce Exposure to Toxic Elements in Foods
FDA Takes Steps to Limit Lead in Juice to Further Reduce Exposure to Toxic Elements in Foods
Categorie: Istituzioni
FDA Roundup: April 26, 2022
The U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency.
Categorie: Istituzioni
Coronavirus (COVID-19) Update: FDA Approves First COVID-19 Treatment for Young Children
Today, the FDA approved the first COVID-19 treatment for children less than 12 years of age.
Categorie: Istituzioni
FDA Roundup: April 22, 2022
The U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency.
Categorie: Istituzioni
FDA Considers New Approach to Improve Safe Disposal of Prescription Opioid Analgesics, Decrease Unnecessary Exposure to Unused Medication
The U.S Food and Drug Administration established a public docket to consider adding a mail-back envelope requirement to the Opioid Analgesic Risk Evaluation and Mitigation Strategy to require that all opioid analgesics, including immediate-release, extended-release, and long-acting formulations, use
Categorie: Istituzioni
FDA Roundup: April 19, 2022
The U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency.
Categorie: Istituzioni
