Food and Drug Administration

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FDA Roundup: March 25, 2022

Ve, 25/03/2022 - 22:36
The U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency.
Categorie: Istituzioni

FDA Issues Decisions on Additional E-Cigarette Products

Gi, 24/03/2022 - 18:01
FDA took additional actions as part of the agency’s work to ensure any electronic nicotine delivery system (ENDS) products available for sale have demonstrated that marketing of the products is appropriate for the protection of the public health.
Categorie: Istituzioni

FDA Statement on Medical Device User Fee Amendments (MDUFA)

Ma, 22/03/2022 - 21:44
FDA and representatives from the medical device industry have reached an agreement on proposed recommendations for the fifth reauthorization of the medical device user fee program.
Categorie: Istituzioni

FDA Roundup: March 22, 2022

Ma, 22/03/2022 - 21:27
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 to Hold Advisory Committee Meeting on COVID-19 Vaccines to Discuss Future Boosters

Lu, 21/03/2022 - 15:02
On Wed., April 6, FDA will hold a virtual meeting of its Vaccines and Related Biological Products Advisory Committee to discuss considerations for future COVID-19 vaccine booster doses and the strain selection process to address current and emerging variants during the Fall season 2022.
Categorie: Istituzioni

FDA Roundup: March 18, 2022

Ve, 18/03/2022 - 21:37
The U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency.
Categorie: Istituzioni

FDA, Reagan-Udall Foundation to Hold Important Public Workshop to Discuss Naloxone Access

Gi, 17/03/2022 - 19:08
The U.S. Food and Drug Administration in collaboration with the Reagan-Udall Foundation for the FDA will hold a virtual public workshop to discuss critical questions around access to naloxone, a drug used to reverse opioid overdoses.
Categorie: Istituzioni

FDA Roundup: March 15, 2022

Ma, 15/03/2022 - 21:42
The U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency.
Categorie: Istituzioni

FDA Approves First Generic of Symbicort to Treat Asthma and COPD

Ma, 15/03/2022 - 21:36
The FDA approved the first generic of Symbicort for the treatment of asthma and for the maintenance treatment of patients with COPD.
Categorie: Istituzioni

FDA Roundup: March 11, 2022

Ve, 11/03/2022 - 23:32
The U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency.
Categorie: Istituzioni

FDA Orders Philips Respironics to Notify Patients Regarding the Recall of Certain Breathing Assistance Machines

Ve, 11/03/2022 - 01:26
The FDA issued a notification order to Philips Respironics requiring the company to notify patients and others of the company’s recall of certain Philips Respironics ventilators, continuous positive airway pressure and bilevel positive airway pressure machines.
Categorie: Istituzioni

FDA Roundup: March 8, 2022

Ma, 08/03/2022 - 23:16
The U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency.
Categorie: Istituzioni

FDA Makes Low-Risk Determination for Marketing of Products from Genome-Edited Beef Cattle After Safety Review

Lu, 07/03/2022 - 18:24
FDA Makes Low-Risk Determination for Marketing of Products from Genome-Edited Beef Cattle After Safety Review; Agency’s First Enforcement Discretion Decision for an IGA in an Animal for Food Use
Categorie: Istituzioni

FDA Roundup: March 4, 2022

Ve, 04/03/2022 - 22:04
The U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency.
Categorie: Istituzioni

FDA Urges Companies to be ’Recall Ready’ to Protect Public Health as Part of Final Guidance for Voluntary Recalls

Gi, 03/03/2022 - 19:58
FDA issues guidance to help companies prepare to quickly and effectively remove violative products from the market and limit the public’s exposure to risk.
Categorie: Istituzioni

FDA Roundup: March 1, 2022

Ma, 01/03/2022 - 23:00
The U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency.
Categorie: Istituzioni

FDA Clinical Trial Guidances Share Biden Administration’s Goals for Advancing Development of Cancer Treatments

Ma, 01/03/2022 - 17:55
FDA Clinical Trial Guidances Share Biden Administration’s Goals for Advancing Development of Cancer Treatments
Categorie: Istituzioni

FDA Roundup: February 25, 2022

Ve, 25/02/2022 - 22:46
The U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency.
Categorie: Istituzioni

FDA Approves Treatment for Wider Range of Patients with Heart Failure

Gi, 24/02/2022 - 19:35
The FDA approved a drug to reduce the risk of cardiovascular death and hospitalization for heart failure in adults. The approval will provide a treatment option for a wider range of patients with heart failure.
Categorie: Istituzioni

FDA Permits Marketing of First Condom Specifically Indicated for Anal Intercourse

Me, 23/02/2022 - 18:09
FDA authorized the marketing of the first condoms specifically indicated to help reduce transmission of sexually transmitted infections (STIs) during anal intercourse.
Categorie: Istituzioni