Search for: "FOOD AND DRUG ADMINISTRATION"
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29 Jul 2010, 10:14 am
Johnson & Johnson has agreed to a $75 Million national settlement related to allegations that its subsidiary, Ortho-McNeil-Janssen Pharmaceuticals schemed to improperly market the drug Topamax for uses that were not approved by the Food & Drug Administration. [read post]
24 Aug 2007, 11:51 am
Food & Drug Administration has "exclusive authority" to regulate prescripton drug advertising. [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The US Food and Drug Administration (FDA) issued draft guidance, providing recommendations to sponsors who are considering submitting a non-interventional study (i.e., an observational study) to FDA to support the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]
2 Feb 2021, 10:00 pm
January was a busy month for the US Food and Drug Administration’s precision medicine efforts, as the agency produced guidance on ASO drugs for patients with debilitating or life-threatening genetic disorders and guidance on manufacturing considerations for certain cellular and gene therapy products during the COVID-19 pandemic. [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The US Food and Drug Administration (FDA) issued draft guidance, providing recommendations to sponsors who are considering submitting a non-interventional study (i.e., an observational study) to FDA to support the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]
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The US Food and Drug Administration (FDA) on February 1 issued a draft guidance, “Formal Meetings Between FDA and Sponsors or Requestors of OTC Monograph Drugs” (Meeting Guidance), that specifies the procedures and principles for meetings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]
6 Apr 2016, 11:08 am
Decision, by Erik Eckholm: The Food and Drug Administration recently relaxed its guidelines for use of the abortion-inducing drug mifepristone, which is used in approximately one... [read post]
30 Sep 2024, 10:00 pm
Aiming to expedite drug development, enhance the body of clinical evidence supporting new and existing therapies, and improve participation and diversity in clinical trial populations, the US Food and Drug Administration (FDA) recently issued three guidance documents that impacted the clinical trial landscape and established a new hub for clinical trial innovation. [read post]
30 Sep 2024, 10:00 pm
Aiming to expedite drug development, enhance the body of clinical evidence supporting new and existing therapies, and improve participation and diversity in clinical trial populations, the US Food and Drug Administration (FDA) recently issued three guidance documents that impacted the clinical trial landscape and established a new hub for clinical trial innovation. [read post]
30 Sep 2024, 10:00 pm
Aiming to expedite drug development, enhance the body of clinical evidence supporting new and existing therapies, and improve participation and diversity in clinical trial populations, the US Food and Drug Administration (FDA) recently issued three guidance documents that impacted the clinical trial landscape and established a new hub for clinical trial innovation. [read post]
30 Sep 2024, 10:00 pm
Aiming to expedite drug development, enhance the body of clinical evidence supporting new and existing therapies, and improve participation and diversity in clinical trial populations, the US Food and Drug Administration (FDA) recently issued three guidance documents that impacted the clinical trial landscape and established a new hub for clinical trial innovation. [read post]
30 Sep 2024, 10:00 pm
Aiming to expedite drug development, enhance the body of clinical evidence supporting new and existing therapies, and improve participation and diversity in clinical trial populations, the US Food and Drug Administration (FDA) recently issued three guidance documents that impacted the clinical trial landscape and established a new hub for clinical trial innovation. [read post]
30 Sep 2024, 10:00 pm
Aiming to expedite drug development, enhance the body of clinical evidence supporting new and existing therapies, and improve participation and diversity in clinical trial populations, the US Food and Drug Administration (FDA) recently issued three guidance documents that impacted the clinical trial landscape and established a new hub for clinical trial innovation. [read post]
16 Nov 2018, 9:57 pm
Food and Drug Administration and the Michigan Department of Agriculture and Rural Development tested positive for the presence of Listeria monocytogenes. [read post]
22 Nov 2011, 2:52 pm
There are older, proven drugs that can be recommended as a substitute The Food and Drug Administration could be doing more to alert consumers to the dangers of certain drugs. [read post]
8 Nov 2011, 5:34 am
Food and Drug Administration (FDA) recently sent a warning letter to Snokist Growers of Yakima, Wash., claiming that the food providers were unable to make sure that their fruit puree and applesauce was reconditioned for consumption. [read post]
14 Aug 2022, 9:05 pm
The original compliance date was January 2022, but the Food and Drug Administration has delayed it. [read post]
22 Sep 2013, 10:05 pm
Food and Drug Administration (FDA) found the premises were infested with rodents and insects. [read post]
9 Dec 2019, 8:03 pm
On Dec. 6, the Food and Drug Administration and the Pennsylvania Department of Health advised that the foodservice companies who received the fruit salad to not sell or serve it. [read post]
10 Dec 2014, 10:01 pm
Food and Drug Administration should approach the regulation of genetically engineered (GE) food — and particularly its labeling, or lack thereof — was the topic of a hearing by the House Energy & Commerce Committee on Wednesday. [read post]
