Istituzioni

FDA Issues Final Guidance for Certain Labeling Recommendations for Breast Implants

Food and Drug Administration - Mar, 29/09/2020 - 00:16
FDA issued guidance for certain labeling recommendations for breast implants as part of the agency’s effort to improve the information available to patients and health care professionals about the risks of breast implants.
Categorie: Istituzioni

FDA Approves First Drug to Treat Group of Rare Blood Disorders in Nearly 14 Years

Food and Drug Administration - Ven, 25/09/2020 - 22:00
Today FDA approved Nucala (mepolizumab) for adults and children aged 12 years and older with hypereosinophilic syndrome (HES) for six months or longer without another identifiable non-blood related cause of the disease.
Categorie: Istituzioni

Coronavirus (COVID-19) Update: Daily Roundup September 25, 2020

Food and Drug Administration - Ven, 25/09/2020 - 21:53
FDA issues an updated summary of the agency’s COVID-19 response efforts.
Categorie: Istituzioni

FDA Takes Actions to Help Lower U.S. Prescription Drug Prices

Food and Drug Administration - Gio, 24/09/2020 - 23:51
Today, HHS and FDA took actions to help provide safe, effective, and more affordable drugs to American patients by completing the rulemaking to allow states to import certain prescription drugs from Canada.
Categorie: Istituzioni

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

Food and Drug Administration - Gio, 24/09/2020 - 22:52
Coronavirus (COVID-19) Update: Daily Roundup
Categorie: Istituzioni

FDA Issues Recommendations for Certain High-Risk Groups Regarding Mercury-Containing Dental Amalgam

Food and Drug Administration - Gio, 24/09/2020 - 19:33
FDA issues updated recommendations on dental amalgam and potential risks to certain high-risk individuals that may be associated with mercury-containing fillings used to restore the missing structure and surfaces of a decayed tooth.
Categorie: Istituzioni

Coronavirus (COVID-19) Update: FDA Authorizes First Point-of-Care Antibody Test for COVID-19

Food and Drug Administration - Gio, 24/09/2020 - 02:40
Today, the FDA issued an emergency use authorization (EUA) for the first serology (antibody) point-of-care (POC) test for COVID-19.
Categorie: Istituzioni

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

Food and Drug Administration - Gio, 24/09/2020 - 00:16
Coronavirus (COVID-19) Update: Daily Roundup
Categorie: Istituzioni

FDA Requiring Labeling Changes for Benzodiazepines

Food and Drug Administration - Mer, 23/09/2020 - 20:52
FDA issues a Drug Safety Communication announcing a class-wide labeling change for benzodiazepines to include the risks of abuse, misuse, addiction, physical dependence and withdrawal reactions to help improve their safe use.
Categorie: Istituzioni

FDA Achieves Key Milestone, Finalizes Framework That Will Resume Shellfish Trade with Europe for the First Time in 10 Years

Food and Drug Administration - Mer, 23/09/2020 - 18:10
FDA finalized a molluscan shellfish equivalence determination for two European Union (EU) Member States, Spain and the Netherlands
Categorie: Istituzioni

FDA Launches the Digital Health Center of Excellence

Food and Drug Administration - Mar, 22/09/2020 - 18:26
FDA launches the Digital Health Center of Excellence within CDRH, furthering FDA’s dedication to the advancement of digital health technology - including mobile health devices, Software as a Medical Device, wearables when used as a medical device, and technologies used to study medical products.
Categorie: Istituzioni

FDA Clarifies Types of Evidence Relevant to Determining the “Intended Use” of FDA-Regulated Products

Food and Drug Administration - Mar, 22/09/2020 - 15:52
FDA proposal to clarify regulations about the types of evidence relevant to determining how a manufacturer intends for its product to be used by health care providers and patients, an area known as intended use.
Categorie: Istituzioni

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

Food and Drug Administration - Lun, 21/09/2020 - 23:24
FDA’s actions on a new video for consumers and an updated guidance in its ongoing response to the COVID-19 pandemic.
Categorie: Istituzioni

FDA Announces Key FSMA Rule to Advance Traceability of Foods, A Major Milestone in the New Era of Smarter Food Safety

Food and Drug Administration - Lun, 21/09/2020 - 19:28
The FDA has proposed a new rule that lays the foundation for end-to-end food traceability across the food industry that we’ll be working toward over the next decade as part of the New Era of Smarter Food Safety initiative.
Categorie: Istituzioni

Coronavirus (COVID-19) Update: Daily Roundup September 18, 2020

Food and Drug Administration - Ven, 18/09/2020 - 23:08
FDA’s action on a reissued Emergency Use Authorization in its ongoing response to the COVID-19 pandemic.
Categorie: Istituzioni

Coronavirus (COVID-19) Update: Daily Roundup September 17, 2020

Food and Drug Administration - Gio, 17/09/2020 - 23:36
FDA’s actions on a new abbreviated drug application approval and a warning to consumers and health care professionals in its ongoing response to the COVID-19 pandemic.
Categorie: Istituzioni

Coronavirus (COVID-19) Update: Daily Roundup September 16, 2020

Food and Drug Administration - Mer, 16/09/2020 - 23:02
Coronavirus (COVID-19) Update: Daily Roundup for September 16, 2020
Categorie: Istituzioni

Coronavirus (COVID-19) Update: FDA Publishes Comparative Performance Data for COVID-19 Molecular Diagnostic Tests

Food and Drug Administration - Mar, 15/09/2020 - 23:33
The FDA published comparative performance data for some authorized COVID-19 molecular diagnostic tests.
Categorie: Istituzioni

Coronavirus (COVID-19) Update: Daily Roundup September 15, 2020

Food and Drug Administration - Mar, 15/09/2020 - 22:32
FDA issues two warning letters in its ongoing response to the COVID-19 pandemic.
Categorie: Istituzioni

FDA issues first injunction under Produce Safety Rule to Illinois-based food manufacturer for repeated food safety violations

Food and Drug Administration - Mar, 15/09/2020 - 19:10
FDA announced that an Illinois-based food manufacturer has agreed to stop production until it undertakes remedial action and complies with the Federal Food, Drug, and Cosmetic Act.
Categorie: Istituzioni