For Immediate Release: January 05, 2024 Today, the U.S. Food and Drug Administration authorized Florida’s Agency for Health Care Administration’s drug importation program under section 804 of the Federal Food, Drug, and Cosmetic Act (FD&C Act). This is …
For Immediate Release: May 01, 2024 Today, the U.S. Food and Drug Administration took important steps to advance the FDA’s regulatory process for intentional genomic alterations (IGAs) in animals. The updated guidance documents underscore the agency’s …
For Immediate Release: March 01, 2024 Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency: Today, the FDA issued a letter of enforcement discretion for certain qualified health claims regarding …
For Immediate Release: January 02, 2024 Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency: On Dec. 31, 2023, the FDA alerted parents, caregivers and health care providers that Reckitt/Mead …
For Immediate Release: December 22, 2023 Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency: The FDA does not anticipate issuing the FDA Roundup during the week of Dec. 25 and intends to resume …
For Immediate Release: December 19, 2023 Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency: Related Information ### Boilerplate The FDA, an agency within the U.S. Department of Health and Human …
For Immediate Release: December 15, 2023 Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency: Today, the FDA updated the breast implants web pages to share the latest information on: Risks and …
For Immediate Release: December 14, 2023 The U.S. District Court for the District of Massachusetts has entered a consent decree of permanent injunction ordering Pharmasol Corporation, a Massachusetts-based company, and President Marc L. Badia to stop …
For Immediate Release: December 14, 2023 Today, the U.S. Food and Drug Administration is announcing the issuance of nine warning letters to manufacturers and distributors of unapproved and misbranded antimicrobial animal drugs for violations of federal law …
For Immediate Release: December 14, 2023 Today, the U.S. Food and Drug Administration, in collaboration with U.S. Customs and Border Protection (CBP), announced the seizure of approximately 1.4 million units of unauthorized e-cigarette products, including …
FDA News Release Additional Changes Showcase Agency-wide Impact of Proposal For Immediate Release: December 13, 2023 Today, the U.S. Food and Drug Administration is providing an update on its efforts to create a unified Human Foods Program (HFP) and new …
For Immediate Release: December 12, 2023 Today, the U.S. Food and Drug Administration announced it is creating a new advisory committee related to potential treatments for genetic metabolic diseases. Genetic metabolic diseases are conditions that disrupt …
For Immediate Release: November 28, 2023 Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency: Today, the FDA issued a drug safety communication warning that the antiseizure medicines levetiracetam …
For Immediate Release: November 28, 2023 Today, as part of the U.S. Food and Drug Administration’s continued commitment to protect and promote the public health, the agency is alerting patients and healthcare providers of an emerging safety issue involving …
For Immediate Release: November 27, 2023 Today, the U.S. Food and Drug Administration approved Ogsiveo (nirogacestat) tablets for adult patients with progressing desmoid tumors who require systemic treatment. Ogsiveo is the first drug to be approved for …
For Immediate Release: November 21, 2023 Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency: Today, the FDA issued a safety communication to provide additional information about the voluntary …
For Immediate Release: November 17, 2023 Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency: Today, to mark the 15th anniversary of the FDA foreign offices, the FDA published an interview with …
For Immediate Release: November 16, 2023 Yesterday, the U.S. Food and Drug Administration announced that a dietary supplement distributor, manufacturer, and two executives have been ordered by a federal court to stop producing and selling their products …
FDA News Release Today’s Action also Opens the 510(k) Pathway for Other Tests for These Infections with At-Home Sample Collection For Immediate Release: November 15, 2023 Today, the U.S. Food and Drug Administration granted marketing authorization to …
For Immediate Release: November 15, 2023 Today, the U.S. District Court for the District of Arizona entered a consent decree of permanent injunction ordering Smart Women’s Choice, Inc., an Arizona-based company, and Jennifer A. Richard, its chief executive …
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