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7 Dec 2023, 10:00 pm
The US Food and Drug Administration (FDA) received thousands of comments on its recently proposed rule that would make clear the FDA’s authority to regulate laboratory developed tests (LDTs) as medical devices by adding 10 words to the definition of in vitro diagnostic products (IVDs): “including when the manufacturer of these products is a laboratory. [read post]
7 Jan 2011, 7:39 am
The Food and Drug Administration (FDA) is launching a website called "FDA Basics for Industry" this year. [read post]
7 Dec 2023, 10:00 pm
The US Food and Drug Administration (FDA) received thousands of comments on its recently proposed rule that would make clear the FDA’s authority to regulate laboratory developed tests (LDTs) as medical devices by adding 10 words to the definition of in vitro diagnostic products (IVDs): “including when the manufacturer of these products is a laboratory. [read post]
7 Dec 2023, 10:00 pm
The US Food and Drug Administration (FDA) received thousands of comments on its recently proposed rule that would make clear the FDA’s authority to regulate laboratory developed tests (LDTs) as medical devices by adding 10 words to the definition of in vitro diagnostic products (IVDs): “including when the manufacturer of these products is a laboratory. [read post]
7 Dec 2023, 10:00 pm
The US Food and Drug Administration (FDA) received thousands of comments on its recently proposed rule that would make clear the FDA’s authority to regulate laboratory developed tests (LDTs) as medical devices by adding 10 words to the definition of in vitro diagnostic products (IVDs): “including when the manufacturer of these products is a laboratory. [read post]
7 Dec 2023, 10:00 pm
The US Food and Drug Administration (FDA) received thousands of comments on its recently proposed rule that would make clear the FDA’s authority to regulate laboratory developed tests (LDTs) as medical devices by adding 10 words to the definition of in vitro diagnostic products (IVDs): “including when the manufacturer of these products is a laboratory. [read post]
27 Oct 2010, 5:45 pm
The Associated Press is reporting that the Food and Drug Administration has "cited drugmaker Bristol-Myers Squibb Co. for multiple deficiencies at its Puerto Rico manufacturing plant, including glass particles in drug vials and possible contamination of sterile drug products. [read post]
2 Mar 2018, 9:00 pm
The recall falls on the heels of the Food and Drug Administration’s investigation into the pet deaths, according to the recall notice on the agency’s website. [read post]
1 Oct 2013, 12:59 pm
The Food and Drug Administration responded Monday to a four-year-old petition from the Center for Food Safety and the Institute for Agriculture and Trade Policy stating that the agency was in the process of formally withdrawing approval for the use of arsenic-based drugs in animal feed. [read post]
12 Dec 2021, 9:01 pm
As part of its enforcement activities, the Food and Drug Administration sends warning letters to entities under its jurisdiction. [read post]
22 Jan 2023, 9:01 pm
As part of its enforcement activities, the Food and Drug Administration sends warning letters to entities under its jurisdiction. [read post]
3 Nov 2021, 1:15 pm
Federal Food and Drug Administration (FDA) recently sent a letter to the U.S. [read post]
3 Nov 2021, 1:15 pm
Federal Food and Drug Administration (FDA) recently sent a letter to the U.S. [read post]
17 Jan 2011, 1:59 am
Food and Drug Administration (FDA) will do little more than respond to outbreaks are over. [read post]
19 Dec 2023, 10:00 pm
As the close of 2023 approaches, the US Food and Drug Administration (FDA) has issued draft guidance detailing its new Advanced Manufacturing Technologies Designation Program, intended to facilitate the development and accelerate the review of drugs and biological products manufactured using an advanced manufacturing technology (AMT) that has been designated under the program. [read post]
29 Jun 2022, 2:00 am
J. (2022): This Article argues that the Food and Drug Administration (“FDA”) should regulate drug manufacturer speech about off-label uses based on the evidentiary support for the relevant use. [read post]
31 Jul 2007, 4:56 pm
Here's an excerpt:A Food and Drug Administration advisory committee found that GlaxoSmithKline PLC's... [read post]
24 Mar 2024, 10:00 pm
The US Food and Drug Administration (FDA) issued draft guidance, providing recommendations to sponsors who are considering submitting a non-interventional study (i.e., an observational study) to FDA to support the demonstration of substantial evidence of effectiveness and/or evidence of safety of a drug or biologic, as another chapter in its evolution toward the use of real-world evidence (RWE). [read post]
23 Jul 2020, 9:00 pm
Law News 3 (2020): Over the past century, Congress has made the Food & Drug Administration (FDA) responsible for regulating the safety and efficacy of drugs... [read post]
13 Feb 2022, 10:00 pm
The US Food and Drug Administration (FDA) on February 1 issued a draft guidance, “Formal Meetings Between FDA and Sponsors or Requestors of OTC Monograph Drugs” (Meeting Guidance), that specifies the procedures and principles for meetings between FDA and meeting requestors. [read post]
