Search for: "FOOD AND DRUG ADMINISTRATION"
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20 Jun 2012, 10:00 am
(KV) for making false or misleading statements to the US Food and Drug Administration (FDA). [read post]
11 Apr 2024, 9:00 am
On April 4, 2024, the Food and Drug Administration (FDA) issued its “New Dietary Ingredient Notification Master Files for Dietary Supplements: Guidance for Industry” (“Draft Guidance”). [read post]
5 Aug 2021, 7:38 pm
Food and Drug Administration approved an interchangeable biosimilar to insulin glargine, an approval notable because it is the first approved interchangeable biosimilar product. [read post]
5 Aug 2010, 7:11 am
[JURIST] Vague language and inconsistent interpretations of policy have hindered the Food and Drug Administration's (FDA) [website] ability to effectively evaluate and approve medical devices, according to a new FDA report [text, PDF] released Wednesday. [read post]
8 Feb 2017, 10:43 am
Food and Drug Administration (FDA) has issued a recall of the Bard Halo One Thin-Walled Guiding Sheath, a device used to place interventional and diagnostic devices into patients’ arteries and veins via an incision in the leg. [read post]
13 Jun 2016, 10:00 am
., Board Certified by The Florida Bar in Health Law On May 17, 2016, the United States Food and Drug Administration (FDA) published a draft guidance titled “Use of Electronic Health Record Data in Clinical Investigations” (Draft Guidance) which emphasizes interoperability and outlines other best practices for effectively using EHR data in FDA-regulated studies. [read post]
9 Sep 2013, 3:06 pm
Food and Drug Administration (FDA) issued several warnings about sex supplements and male enhancement products that purport to be “all natural,” but in fact contain traces of prescription-strength medication.More here. [read post]
31 Jul 2018, 9:04 pm
Food and Drug Administration announced a new initiative, the Biosimilars Action Plan: Balancing Innovation and Competition in furtherance of its efforts "to ensure that this balance between innovation and competition exists across the spectrum of pharmaceutical products. [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]
Franck's Pharmacy Announces Compounding Prescriptions Recall, Shuts Down Sterile Compounding Service
1 Jun 2012, 10:00 am
The recall was apparently prompted by action by the US Food and Drug Administration (FDA).... [read post]
28 Nov 2022, 9:07 pm
Food and Drug Administration (FDA) announced its approval of Eli Lilly's Rezvoglar (insulin glargine-aglr) product as an interchangeable biosimilar to Sanofi's Lantus (insulin glargine). [read post]
12 Sep 2018, 7:07 am
FDA Looks to Make FOIA Process EasierBy Zachary Brennan, Regulatory Focus, Sept. 12, 2018The US Food and Drug Administration (FDA) on Wednesday proposed a new rulemaking that would ease the process by which the public can use the Freedom of Information Act (FOIA) to request certain non-public information.In addition to easing the process by which materials can be requested, the proposed rule will require FDA to establish procedures for identifying records of general… [read post]
3 Sep 2019, 5:59 am
., law firm that plans to try to provide answers later this month.The firm, Buchanan Ingersoll & Rooney, said it will stage a webinar on Sept. 17 to explain Food and Drug Administration "regulations and enforcement, and how stem cell stakeholders (pharma/biotech companies, healthcare providers) can best comply. [read post]
6 Oct 2023, 7:46 am
Food and Drug Administration (FDA), and the U.S. [read post]
28 Nov 2012, 2:13 pm
Food and Drug Administration (FDA) and the U.S. [read post]
9 Jan 2013, 9:46 am
Federal regulators have quietly stepped in to inspect another Massachusetts pharmacy similar to New England Compounding Center, the Framingham company blamed for the national fungal meningitis outbreak that sickened more than 660 people and killed 40.Food and Drug Administration workers recently joined state officials, who have been conducting surprise inspections of compounders, to inspect one pharmacy because regulators determined the company’s actions fell… [read post]
28 Dec 2015, 10:37 am
A recent analysis by the Food and Drug Administration (FDA) had shown undeclared sibutramine and phenolphthalein in the Company's 3 dietary supplements.Sibutramine is a medication that assists with weight-loss by altering neurotransmitters within the brain. [read post]
7 Jul 2014, 8:49 pm
The Food and Drug Administration has received numerous reports of blood clots in the veins of patients taking testosterone therapy products. [read post]
5 Jun 2014, 6:07 pm
Food and Drug Administration is updating its advice for pregnant women on the appropriate levels of mercury in seafood. [read post]
11 Nov 2007, 8:49 pm
Medtronic has stopped selling its defibrillator leads and critics have begun examining how safety concerns had been previously handled by the company and the Food and Drug Administration. [read post]
