Istituzioni

FDA Takes Steps Aimed at Improving Quality, Safety and Efficacy of Sunscreens

Food and Drug Administration - Ven, 24/09/2021 - 15:23
Today, the FDA took steps aimed at improving the quality, safety, and efficacy of sunscreens as part of its implementation of new authorities for certain over-the-counter (OTC) drugs.
Categorie: Istituzioni

FDA Authorizes Booster Dose of Pfizer-BioNTech COVID-19 Vaccine for Certain Populations

Food and Drug Administration - Gio, 23/09/2021 - 01:27
FDA amended the emergency use authorization (EUA) for the Pfizer-BioNTech COVID-19 Vaccine to allow for the use of a single booster dose, to be administered at least six months after completion of the primary series with the Pfizer-BioNTech COVID-19 Vaccine in certain populations.
Categorie: Istituzioni

FDA In Brief: FDA Publishes Material Safety Data to Promote Safer, More Effective Medical Devices

Food and Drug Administration - Mer, 22/09/2021 - 21:56
FDA releases profiles from a nonprofit organization on the current state of knowledge about medical device material performance after implantation.
Categorie: Istituzioni

FDA Issues Draft Guidance on Donor Eligibility and Manufacturing of Cellular Therapies for Animals

Food and Drug Administration - Mer, 22/09/2021 - 15:37
FDA issues two draft guidance documents focused on donor eligibility and current good manufacturing practices for manufacturers of animal cells, tissues, and cell- and tissue-based products that, if finalized, may help support the development of promising and innovative products that can benefit ani
Categorie: Istituzioni

FDA Authorizes Software that Can Help Identify Prostate Cancer

Food and Drug Administration - Mar, 21/09/2021 - 19:54
FDA authorizes software to assist pathologists detect areas that are suspicious for cancer as an adjunct to the standard of care review of digitally-scanned slide images from prostate biopsies.
Categorie: Istituzioni

FDA Approves First Biosimilar to Treat Macular Degeneration Disease and Other Eye Conditions

Food and Drug Administration - Lun, 20/09/2021 - 17:04
FDA Approves First Biosimilar to Treat Macular Degeneration Disease and Other Eye Conditions
Categorie: Istituzioni

FDA In Brief: FDA Posts an Initial Batch of Four Deemed Final Administrative Orders for Over-the-Counter Drugs

Food and Drug Administration - Lun, 20/09/2021 - 16:27
Today, the FDA posted an initial batch of four deemed final administrative orders as part of the Over-the-Counter Monograph Reform under the Coronavirus Aid, Relief, and Economic Security Act
Categorie: Istituzioni

Coronavirus (COVID-19) Update: September 17, 2021

Food and Drug Administration - Ven, 17/09/2021 - 21:05
Coronavirus (COVID-19) Update: September 17, 2021
Categorie: Istituzioni

Federal Court Enters Consent Decree Against Florida Compounder, Prohibiting Manufacture and Distribution of Drugs Due to Insanitary Conditions

Food and Drug Administration - Ven, 17/09/2021 - 17:53
A Federal court has entered a consent decree against a Florida compounder, prohibiting the manufacture and distribution of drugs due to insanitary conditions
Categorie: Istituzioni

FDA In Brief: FDA Hosts Third Summit Focused on Reducing the Availability of Opioids Online

Food and Drug Administration - Ven, 17/09/2021 - 16:56
The U.S. Food and Drug Administration hosted its third Online Opioid Summit, “Reducing the Availability of Opioids Online,” as part of the agency’s efforts to address the illegal availability of opioids online.
Categorie: Istituzioni

FDA Advances Data, IT Modernization Efforts with New Office of Digital Transformation

Food and Drug Administration - Mer, 15/09/2021 - 21:25
The FDA announces reorganization of the information technology, data and cybersecurity offices into the agency-level Office of Digital Transformation and Vid Desai as the agency’s Chief Information Officer.
Categorie: Istituzioni

FDA In Brief: FDA Announces Winners of Food Traceability Challenge

Food and Drug Administration - Lun, 13/09/2021 - 16:56
FDA announces winners of New Era of Smarter Food Safety Low- or No-Cost Tech-enabled Traceability Challenge
Categorie: Istituzioni

Coronavirus (COVID-19) Update: September 10, 2021

Food and Drug Administration - Ven, 10/09/2021 - 21:23
Coronavirus (COVID-19) Update: September 10, 2021
Categorie: Istituzioni

FDA Will Follow The Science On COVID-19 Vaccines For Young Children

Food and Drug Administration - Ven, 10/09/2021 - 15:21
FDA leadership outlines steps the FDA will take to ensure the safety and efficacy of COVID-19 vaccines for young children
Categorie: Istituzioni

FDA Makes Significant Progress in Science-Based Public Health Application Review, Taking Action on Over 90% of More Than 6.5 Million ‘Deemed’ New Tobacco Products Submitted

Food and Drug Administration - Gio, 09/09/2021 - 20:31
FDA made significant progress since Sept, 9, 2020, working diligently to better understand these ENDS products and have taken action on about 93% of the total timely-submitted applications.
Categorie: Istituzioni

FDA, FTC Warn 10 Companies Illegally Selling Dietary Supplements Claiming to Treat Diabetes

Food and Drug Administration - Gio, 09/09/2021 - 18:28
Today, the FDA and FTC posted warning letters to 10 companies for selling dietary supplements claiming to treat diabetes
Categorie: Istituzioni

FDA In Brief: As Consumers Order More Meals and Groceries Online, FDA Plans Public Meeting to Address Food Safety Risks

Food and Drug Administration - Gio, 09/09/2021 - 17:13
The FDA will meet with members of the food industry, regulatory counterparts at all levels of government, consumers, and others to enhance our understanding of how human and animal foods are sold through e-commerce business models.
Categorie: Istituzioni

FDA In Brief: FDA Announces Public Workshop to Reconsider Mandatory Prescriber Education for Opioids

Food and Drug Administration - Mer, 08/09/2021 - 16:59
The FDA announces a two-day public workshop to give stakeholders an opportunity to provide input on aspects of the current opioid crisis that could be mitigated in a measurable way by requiring mandatory prescriber education as part of a REMS.
Categorie: Istituzioni

Coronavirus (COVID-19) Update: September 7, 2021

Food and Drug Administration - Mar, 07/09/2021 - 22:06
Coronavirus (COVID-19) Update: September 7, 2021
Categorie: Istituzioni

FDA In Brief: FDA Reaches Milestone in Competitive Generic Therapy Drug Approvals

Food and Drug Administration - Gio, 02/09/2021 - 17:14
FDA In Brief: FDA Reaches Milestone in Competitive Generic Therapy Drug Approvals, Marking Success of Program that Encourages Development of Drugs with Inadequate Generic Competition
Categorie: Istituzioni