Istituzioni

Coronavirus (COVID-19) Update: Daily Roundup April 30, 2020

Food and Drug Administration - Gi, 30/04/2020 - 23:21
Coronavirus (COVID-19) Update: Daily Roundup
Categorie: Istituzioni

Coronavirus (COVID-19) Update: FDA Includes Ventilator Developed by NASA in Ventilator Emergency Use Authorization

Food and Drug Administration - Gi, 30/04/2020 - 22:04
Coronavirus (COVID-19) Update: FDA Includes Ventilator Developed by NASA in Ventilator Emergency Use Authorization
Categorie: Istituzioni

Coronavirus (COVID-19) Update: Daily Roundup April 29, 2020

Food and Drug Administration - Gi, 30/04/2020 - 00:47
Coronavirus (COVID-19) Update: Daily Roundup
Categorie: Istituzioni

FDA Grants Marketing of New Device for Continuous Dialysis Therapy for use in Pediatric Patients with Certain Kidney Conditions

Food and Drug Administration - Me, 29/04/2020 - 18:51
FDA grants marketing authorization for a new device indicated to provide continuous hemodialysis or hemofiltration therapy to critically ill pediatric patients weighing between 2.5 and 10 kilograms (or 5.5 to 22 pounds)
Categorie: Istituzioni

Coronavirus (COVID-19) Update: Daily Roundup April 28, 2020

Food and Drug Administration - Ma, 28/04/2020 - 23:21
Coronavirus (COVID-19) Update: Daily Roundup
Categorie: Istituzioni

Coronavirus (COVID-19) Update: Daily Roundup April 27, 2020

Food and Drug Administration - Ma, 28/04/2020 - 00:15
Coronavirus (COVID-19) Update: Daily Roundup
Categorie: Istituzioni

FDA Warns Manufacturers and Retailers to Remove Certain E-cigarette Products Targeted to Youth from the Market

Food and Drug Administration - Lu, 27/04/2020 - 16:58
FDA issued ten warning letters to retailers and manufacturers who sell, manufacture and/or import unauthorized electronic nicotine delivery system (ENDS) products targeted to youth or likely to promote use by youth.
Categorie: Istituzioni

Coronavirus (COVID-19) Update: FDA Continues to Ensure Availability of Alcohol-Based Hand Sanitizer During the COVID-19 Pandemic, Addresses Safety Concerns

Food and Drug Administration - Lu, 27/04/2020 - 15:21
FDA provides an update on its efforts to ensure the availability of alcohol-based sanitizer
Categorie: Istituzioni

Coronavirus (COVID-19) Update: Daily Roundup April 24, 2020

Food and Drug Administration - Sa, 25/04/2020 - 00:26
Coronavirus (COVID-19) Update: Daily Roundup
Categorie: Istituzioni

FDA Provides Updates on Adverse Event Reports and Postmarket Activities Associated with Essure

Food and Drug Administration - Ve, 24/04/2020 - 19:59
FDA issued a letter to Bayer outlining conditions for submitting additional postmarket information to the agency about Essure. The letter applies to reportable adverse events Bayer is or becomes aware of from social media data received in relation to litigation.
Categorie: Istituzioni

Coronavirus (COVID-19) Update: FDA Reiterates Importance of Close Patient Supervision for ‘Off-Label’ Use of Antimalarial Drugs to Mitigate Known Risks, Including Heart Rhythm Problems

Food and Drug Administration - Ve, 24/04/2020 - 16:01
FDA is reiterating the importance of close patient supervision for ‘off-label’ use of antimalarial drugs to mitigate known risks, including heart rhythm problems.
Categorie: Istituzioni

Coronavirus (COVID-19) Update: Daily Roundup April 23, 2020

Food and Drug Administration - Ve, 24/04/2020 - 00:15
Coronavirus (COVID-19) Update: Daily Roundup
Categorie: Istituzioni

FDA Warns Companies Illegally Selling CBD Products to Treat Medical Conditions, Opioid Addiction

Food and Drug Administration - Gi, 23/04/2020 - 18:43
FDA has issued warning letters to two companies for illegally selling unapproved products containing cannabidiol (CBD) in ways that violate the FD&C Act, including claims that they can treat medical conditions, including opioid addiction.
Categorie: Istituzioni

Coronavirus (COVID-19) Update: Court Grants FDA’s Request for Extension of Premarket Review Submission Deadline for Certain Tobacco Products Because of Impacts from COVID-19

Food and Drug Administration - Gi, 23/04/2020 - 17:43
As a result of the COVID-19 pandemic, FDA requested and was granted by the court, a 120-day extension of the May 12 deadline for premarket applications for e-cigarettes, cigars and other new tobacco products. These premarket applications are now required to be filed by Sept. 9, 2020.
Categorie: Istituzioni

Coronavirus (COVID-19) Update: Daily Roundup April 22, 2020

Food and Drug Administration - Me, 22/04/2020 - 23:41
Coronavirus (COVID-19) Update: Daily Roundup
Categorie: Istituzioni

FDA Approves New Therapy for Triple Negative Breast Cancer That Has Spread, Not Responded to Other Treatments

Food and Drug Administration - Me, 22/04/2020 - 19:03
FDA granted accelerated approval to Trodelvy (sacituzumab govitecan-hziy) for the treatment of adult patients with triple-negative breast cancer that has spread. Patients must have received at least two prior therapies.
Categorie: Istituzioni

Coronavirus (COVID-19) Update: Daily Roundup April 21, 2020

Food and Drug Administration - Me, 22/04/2020 - 01:40
Coronavirus (COVID-19) Update: Daily Roundup
Categorie: Istituzioni

Coronavirus (COVID-19) Update: FDA Authorizes First Test for Patient At-Home Sample Collection

Food and Drug Administration - Ma, 21/04/2020 - 14:37
Coronavirus (COVID-19) Update: FDA Authorizes First Test for Patient At-Home Sample Collection
Categorie: Istituzioni

Coronavirus (COVID-19) Update: Daily Roundup April 20, 2020

Food and Drug Administration - Ma, 21/04/2020 - 00:26
Coronavirus (COVID-19) Update: Daily Roundup
Categorie: Istituzioni

Coronavirus (COVID-19) Update: Serological Test Validation and Education Efforts

Food and Drug Administration - Do, 19/04/2020 - 00:25
FDA provides details about its thinking on antibody tests for COVID-19 and the agency’s approach to making accurate and reliable serology tests widely available.
Categorie: Istituzioni
Condividi contenuti