Food and Drug Administration

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Coronavirus (COVID-19) Update: FDA Approves First COVID-19 Treatment for Young Children

Lu, 25/04/2022 - 19:57
Today, the FDA approved the first COVID-19 treatment for children less than 12 years of age.
Categorie: Istituzioni

FDA Roundup: April 22, 2022

Ve, 22/04/2022 - 21:49
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

Me, 20/04/2022 - 16:17
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

Ma, 19/04/2022 - 22:27
The U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency.
Categorie: Istituzioni

FDA Warns of Risks Associated with Non-Invasive Prenatal Screening Tests

Ma, 19/04/2022 - 21:22
Today, the FDA is warning the public of the risk of false results, inappropriate use and inappropriate interpretation of results with non-invasive prenatal screening tests, also called cell-free DNA tests or non-invasive prenatal tests.
Categorie: Istituzioni

FDA Takes New Steps Regarding Evaluating Public Health Importance of Additional Food Allergens

Lu, 18/04/2022 - 15:53
FDA Takes New Steps Regarding Evaluating Public Health Importance of Additional Food Allergens
Categorie: Istituzioni

FDA Roundup: April 15, 2022

Ve, 15/04/2022 - 22:12
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 Authorizes First COVID-19 Diagnostic Test Using Breath Samples

Gi, 14/04/2022 - 22:45
Today, the FDA issued an emergency use authorization for the first COVID-19 diagnostic test that detects chemical compounds in breath samples associated with a SARS-CoV-2 infection.
Categorie: Istituzioni

FDA Issues Final Guidance on Animal Drug Compounding from Bulk Drug Substances

Me, 13/04/2022 - 16:17
FDA issued a final guidance that will help protect animal health by addressing need for access to certain compounded animal drugs.
Categorie: Istituzioni

FDA Takes Important Steps to Increase Racial and Ethnic Diversity in Clinical Trials

Me, 13/04/2022 - 15:48
The FDA issued a new draft guidance to industry for developing plans to enroll more participants from underrepresented racial and ethnic populations in the U.S. into clinical trials – expanding on the agency’s previous guidances for industry to improve clinical trial diversity.
Categorie: Istituzioni

FDA Roundup: April 12, 2022

Ma, 12/04/2022 - 21:40
The U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency.
Categorie: Istituzioni

FDA and DEA Warn Online Pharmacies Illegally Selling Adderall to Consumers

Ma, 12/04/2022 - 17:29
The U.S. Food and Drug Administration and the U.S. Drug Enforcement Administration have issued joint warning letters to two online sellers of illegal versions of Schedule II stimulants (including amphetamines marketed illicitly as Adderall) that are not FDA approved.
Categorie: Istituzioni

FDA Roundup: April 8, 2022

Ve, 08/04/2022 - 22:47
The U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency.
Categorie: Istituzioni

Joint Statement from CMS Administrator Chiquita Brooks-LaSure and FDA Commissioner Robert M. Califf, M.D., on Ensuring Access to Safe and Effective Treatments

Ve, 08/04/2022 - 19:58
Joint Statement from CMS Administrator Chiquita Brooks-LaSure and FDA Commissioner Robert M. Califf, M.D., on Ensuring Access to Safe and Effective Treatments.
Categorie: Istituzioni

FDA Roundup: April 5, 2022

Ma, 05/04/2022 - 22:01
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 1, 2022

Ve, 01/04/2022 - 21:11
The U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency.
Categorie: Istituzioni

FDA Roundup: March 29, 2022

Ma, 29/03/2022 - 23:46
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 Authorizes Second Booster Dose of Two COVID-19 Vaccines for Older and Immunocompromised Individuals

Ma, 29/03/2022 - 16:30
The FDA authorized a second booster dose of either the Pfizer-BioNTech or the Moderna COVID-19 vaccines for older people and certain immunocompromised individuals.
Categorie: Istituzioni

Federal judge enters consent decree against New Jersey raw animal food manufacturer

Lu, 28/03/2022 - 22:12
A raw animal food manufacturer has been ordered to stop selling products until they come into compliance under the Federal Food, Drug, and Cosmetic Act
Categorie: Istituzioni

FDA Seeks $8.4 Billion to Further Investments in Critical Public Health Modernization, Core Food and Medical Product Safety Programs

Lu, 28/03/2022 - 18:40
FDA is announcing it is requesting a total budget of $8.4 billion as part of the President’s fiscal year 2023 budget for investments in critical public health modernization, core food safety and medical product safety programs.
Categorie: Istituzioni