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5 Feb 2016, 9:00 am
., Board Certified by The Florida Bar in Health Law The Food and Drug Administration (FDA) has great influence on a vast array of issues impacting the medical industry in the US The decisions it makes in 2016 will have a significant impact for health care providers and on the lives of many Americans. [read post]
13 Jun 2018, 4:17 pm
Food and Drug Administration (FDA), certain containers of pre-cut melon has “been linked to a Salmonella outbreak” that has already sickened more than 60 people throughout eight states. [read post]
14 Nov 2023, 6:19 am
Food and Drug Administration (FDA) posted the following documents on the Unified Website for Biotechnology Regulation: As reported in our September 13, 2022, blog item, on September 12, 2022, President Joseph Biden signed an Executive Order creating a National Biotechnology and Biomanufacturing Initiative to accelerate biotechnology innovation and grow America’s bioeconomy across multiple sectors in industries The post USDA, EPA, and FDA Post Report on Stakeholder… [read post]
8 Feb 2024, 10:00 pm
In the FY 2022 HCFAC, DOJ and HHS not only highlighted a series of fraud and abuse enforcement wins, but also indicated increased activity by and with the US Food and Drug Administration (FDA) and the DOJ Consumer Protection Branch (CPB). [read post]
Representatives Send Letter to FDA to Explain Data Exclusivity Provisions of Biosimilars Legislation
9 Jan 2011, 9:59 pm
Joe Barton (R-TX)) who sponsored the follow-on biologics portion of the comprehensive health care reform bill past year (Patient Protection and Affordable Care Act (H.R. 3590, now P.L. 111-148)) have sent a letter to the Food and Drug Administration, purportedly to explain the "legislative intent" of the data exclusivity provisions of the bill. [read post]
29 Apr 2024, 5:00 pm
Food and Drug Administration (“FDA” or the “Agency”) released its long-awaited “Medical Devices; Laboratory Developed Tests” Final Rule (the “Final Rule”) formalizing the Agency’s authority to regulate laboratory developed tests (“LDTs”) as medical devices. [read post]
14 Nov 2023, 6:19 am
Food and Drug Administration (FDA) posted the following documents on the Unified Website for Biotechnology Regulation: As reported in our September 13, 2022, blog item, on September 12, 2022, President Joseph Biden signed an Executive Order creating a National Biotechnology and Biomanufacturing Initiative to accelerate biotechnology innovation and grow America’s bioeconomy across multiple sectors in industries The post USDA, EPA, and FDA Post Report on Stakeholder… [read post]
27 Sep 2016, 5:32 am
Charles Seife in Scientific American tells the story of how, using the “close-hold embargo” and other techniques, the Food and Drug Administration (FDA) and other government agencies shape what you read about them when major initiatives and findings are announced. [read post]
9 Oct 2012, 10:00 am
Voluntary Recall Due to Investigation By the US Food and Drug Administration (FDA).... [read post]
28 Feb 2020, 8:46 am
Food and Drug Administration (FDA) issued a final rule to amend its regulation that defines “biological product. [read post]
8 Feb 2024, 10:00 pm
In the FY 2022 HCFAC, DOJ and HHS not only highlighted a series of fraud and abuse enforcement wins, but also indicated increased activity by and with the US Food and Drug Administration (FDA) and the DOJ Consumer Protection Branch (CPB). [read post]
6 Dec 2020, 10:00 pm
The Food and Drug Administration (FDA) has received two applications for emergency use authorization within the last month with meetings scheduled to begin this week. [read post]
2 Feb 2018, 4:15 pm
Since the discovery, many have called on the Food and Drug Administration to conduct its own investigation into the tainted cosmetics sold by popular "retailers Claire's Stores Inc. and Justice Retail. [read post]
29 Mar 2024, 5:52 am
Food and Drug Administration (FDA), and the U.S. [read post]
8 Feb 2024, 10:00 pm
In the FY 2022 HCFAC, DOJ and HHS not only highlighted a series of fraud and abuse enforcement wins, but also indicated increased activity by and with the US Food and Drug Administration (FDA) and the DOJ Consumer Protection Branch (CPB). [read post]
14 Apr 2024, 10:00 pm
Earlier this year, the US Food and Drug Administration (FDA) published new draft guidance substantially revising the agency’s previous guidance on the Establishment and Operation of Clinical Trial Data Monitoring Committees (DMCs). [read post]
28 Jul 2014, 9:59 pm
Food and Drug Administration (FDA) has accepted its application to market a version of the protein filgrastim. [read post]
28 May 2013, 10:00 am
., Board Certified by The Florida Bar in Health Law The US Food and Drug Administration (FDA) sent out a warning to health care professionals that steroid injections compounded by Main Street Family Pharmacy, LLC, in Tennessee, may be contaminated. [read post]
7 Nov 2021, 9:59 pm
Food and Drug Administration issued Final Guidance entitled "Questions and Answers on Biosimilar Development and the BPCI Act: Guidance for Industry," and Draft Guidance entitled "New and Revised Draft Q&As on Biosimilar Development and the BPCI Act (Revision 2). [read post]
6 Nov 2012, 12:32 pm
According to an Food & Drug Administration (FDA) press release October 31, 2012, Ameridose, Westborough, MA, sister company of the New England Compounding Center, Framingham, MA linked to more than 30 deaths caused by contaminated products, informed its customers of its voluntary recall of all of its products following the FDA's inspection which found "shortcomings in testing procedures". [read post]
