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3 Oct 2023, 2:28 pm
Now the Food and Drug Administration has added another choice – reformulated Novavax shots […] The post US adds updated Novavax shots as fall COVID option appeared first on Maryland Daily Record. [read post]
26 Oct 2021, 10:00 pm
The US Food and Drug Administration (FDA) has finally issued its final rule establishing requirements for the de novo classification process. [read post]
16 Nov 2016, 9:00 am
., Board Certified by The Florida Bar in Health Law A lung cancer vaccine that was developed in Havana, Cuba, will be the first such clinical trial to be approved by The Food and Drug Administration (FDA) for testing in the United States. [read post]
13 Sep 2018, 2:45 am
The Food and Drug Administration published a proposed rule that would implement various revisions to its FOIA regulations in today’s issue of the Federal Register. [read post]
17 Jan 2022, 10:00 pm
In two draft companion guidance documents, the US Food and Drug Administration (FDA) establishes a proposed framework for transitioning medical devices currently marketed under emergency use authorization (EUA) or enforcement policy guidance to permanent marketing authorization. [read post]
9 Sep 2015, 6:31 am
FDA Sends Warning Letter to Powdered Caffeine Manufacturers that the Product is Dangerous The Food and Drug Administration (FDA) has sent official letters to five powdered caffeine manufacturers stating that the product is dangerous and may have caused at least two deaths. [read post]
19 Apr 2016, 10:00 am
., Board Certified by The Florida Bar in Health Law On April 12, 2016, the US Food and Drug Administration (FDA) issued warnings that targeted the allegedly substandard protection of research participants at a hospital in the Mayo Clinic Care Network. [read post]
3 Feb 2011, 7:41 am
Last month the Food and Drug Administration announced a possible link between breast implants and an increased risk of anaplastic large-cell lymphoma, also known as ALCL. [read post]
2 May 2023, 8:19 am
The United States Food and Drug Administration has not updated its guidelines for pharmaceutical guidelines since 2014. [read post]
3 Apr 2024, 10:00 pm
The US Food and Drug Administration (FDA) released a draft guidance on April 3 providing recommendations to sponsors and testing sites on data integrity for bioavailability and bioequivalence (BA/BE) studies. [read post]
4 Feb 2009, 7:20 pm
Under current Food and Drug Administration rules, the agency must consult with companies on the wording of recalls before they can take effect. [read post]
3 Mar 2019, 9:00 am
The Food and Drug Administration (“FDA”) and Federal Trade Commission (“FTC”) have issued joint warning letters focusing on disease claims being made by dietary supplement marketers. [read post]
17 Aug 2021, 6:35 am
Food and Drug Administration (FDA) sent a letter to device manufacturers noting that the agency "is aware of potential confusion and the possibility of inappropriate medical treatment based on the color of the bracelet or wristband provided by a device manufacturer and given to patients to be worn as an identifier of an implanted device. [read post]
19 Oct 2022, 10:00 pm
On October 17, 2022, the US Food and Drug Administration (FDA) implemented revisions to two of its compliance policy guides (CPGs). [read post]
11 Apr 2021, 9:15 am
’s October 2020 pledge not to enforce its COVID-19-related patents during the pandemic, the United States Food & Drug Administration (FDA) granted emergency regulatory approval for two COVID-19 vaccines produced by Moderna and BioNTech (with Pfizer), making these groups the first to ever enter the commercial market with mRNA-based therapies. [read post]
23 Feb 2022, 10:00 pm
After four long years and a series of delays, the US Food and Drug Administration released its proposed rule for amending the Quality System Regulation to be harmonized with ISO 13485:2016. [read post]
2 Aug 2021, 10:00 pm
Food and Drug Administration. [read post]
26 Oct 2021, 10:00 pm
The US Food and Drug Administration (FDA) has finally issued its final rule establishing requirements for the de novo classification process. [read post]
27 Feb 2007, 2:41 pm
Robinson [official profile] Tuesday sentenced former US Food and Drug Administration (FDA) [official website] commissioner Dr. [read post]
16 Aug 2006, 10:31 pm
Until recently, most, including the Food and Drug Administration, have not really discussed any safety concerns associated with any contact lens solutions aside from the recently recalled ReNu with MoistureLoc, manufactured by Bausch & Lomb, which has been linked to serious eye infections that can ultimately lead to blindness. [read post]
