FDA, CDER's Drug Approvals and Programming to Speed Therapeutic Development
Mar 07 2022 FDA I Patrizia Cavazzoni, M.D., Director, Center for Drug Evaluation and Research A rare disease is any disease that...
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OTC Monograph Reform: Overview of Draft Guidance for Formal Meetings
Mar 07 2022 Date: March 29, 2022 Time: 2:00 PM - 3:00 PM ET ABOUT THIS WEBINAR During this webinar, FDA will provide an overview of the...
FDA Regulation, Soaps & Lotions
Mar 03 2022 We provide safety and regulatory information about soaps and lotions. Lotions, soaps, and other cleansers may be regulated as...
FDA Regulation, Cosmetics or Drugs?
Mar 02 2022 The Food and Drug Administration (FDA) warns cosmetics companies when they make claims about their products that classify...
FDA approves drug for adults with rare form of bone marrow disorder
Mar 01 2022 FDA has granted accelerated approval for Vonjo (pacritinib) capsules to treat adults who have a rare form of a bone marrow...
FDA updates Sotrovimab emergency use authorization
Feb 28 2022 [2/25/2022] The U.S. Food and Drug Administration is continually monitoring how authorized and approved treatments for...
FDA authorizes revisions to Evusheld dosing
Feb 28 2022 [2/24/2022] The U.S. Food and Drug Administration has revised the emergency use authorization for Evusheld (tixagevimab...
FDA Approves Treatment for Wider Range of Patients with Heart Failure
Feb 24 2022 Today, the U.S. Food and Drug Administration approved Jardiance (empagliflozin) to reduce the risk of cardiovascular death...
FDA, At-Home OTC COVID-19 Diagnostic Tests
Feb 22 2022 FDA provides information about at-home over-the-counter (OTC) COVID-19 diagnostic tests. These at-home COVID-19 diagnostic...
FDA Alerts the Public to Potentially Contaminated Products from Family Dollar Stores in Six States
Feb 22 2022 Pictured are circulars at a Family Dollar store in Chicago on March 3, 2020.Daniel Acker/Bloomberg/Getty Images Today, the...
FDA Regulation, Development & Approval Process | Drugs
Feb 10 2022 Developing New Drugs American consumers benefit from having access to the safest and most advanced pharmaceutical system in...
FDA Regulation, hand sanitizer
Feb 15 2022 FDA is working with U.S. government partners including the Centers for Disease Control and Prevention (CDC), medical product...
FDA Regulation, Medical Device Classification
Feb 14 2022 The Food and Drug Administration (FDA) has established classifications for approximately 1,700 different generic types of...
FDA, New Monoclonal Antibody for Treatment of COVID-19 that Retains Activity Against Omicron Variant
Feb 14 2022 02/11/2022, The U.S. Food and Drug Administration issued an emergency use authorization (EUA) for a new monoclonal antibody...
What Is the Approval Process for Generic Drugs?
Feb 10 2022 Generic drugs are copies that one company makes of a brand-name drug that was developed by another company. Generally,...
Medical Device, FDA Regulations required for export to the US
Feb 09 2022 When exporting medical devices to the US, what are the regulations? All medical devices imported into the United States...
FDA Regulations : Cosmetics Labeling
Feb 07 2022 This section provides resources on regulatory requirements for cosmetic labeling. For a thorough explanation of cosmetic...
FDA Approves First Generic of Restasis
Feb 02 2022 The U.S. Food and Drug Administration has approved the first generic of Restasis (cyclosporine ophthalmic emulsion) 0.05%...
FDA, Pfizer-BioNTech COVID-19 Vaccine for Children 6 Months Through 4 Years of Age
FDA Advisory Committee Meeting to Discuss Request for Authorization of Pfizer-BioNTech COVID-19 Vaccine for Children 6 Months Through 4...
FDA Takes Key Action by Approving Second COVID-19 Vaccine
Jan 31 2022 Today, the U.S. Food and Drug Administration approved a second COVID-19 vaccine. The vaccine has been known as the Moderna...
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