Search for: "FOOD AND DRUG ADMINISTRATION"
Results 2061 - 2080
of 23,781
Sorted by Relevance
|
Sort by Date
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The US Food and Drug Administration (FDA) issued draft guidance, providing recommendations to sponsors who are considering submitting a non-interventional study (i.e., an observational study) to FDA to support the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]
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As the close of 2023 approaches, the US Food and Drug Administration (FDA) has issued draft guidance detailing its new Advanced Manufacturing Technologies Designation Program, intended to facilitate the development and accelerate the review of drugs and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]
18 Feb 2014, 11:08 am
As FDA Declares It Will Study Testosterone Therapy, Endocrine Society Calls for Longer, More Thorough Studies of the Drug At the end of January of this year, the Food and Drug Administration (FDA) said that it would investigate claims that testosterone therapy approved by the agency could lead to serious heart conditions in users, including […] [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]
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As the close of 2023 approaches, the US Food and Drug Administration (FDA) has issued draft guidance detailing its new Advanced Manufacturing Technologies Designation Program, intended to facilitate the development and accelerate the review of drugs and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]
17 Jan 2022, 8:16 am
From Fox News: Last month, the Food and Drug Administration cited its adverse event (AE) reporting data in justifying its decision to remove the drug's in-person requirement. [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As the close of 2023 approaches, the US Food and Drug Administration (FDA) has issued draft guidance detailing its new Advanced Manufacturing Technologies Designation Program, intended to facilitate the development and accelerate the review of drugs and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]
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 Jan 2023, 5:08 am
Food and Drug Administration finalized a regulatory change on Tuesday that allows retail pharmacies to offer abortion pills. [read post]
2 Apr 2007, 7:08 pm
Food and Drug Administration (FDA) regarding Cephalon's Nuvigil ® (armodafinil) new drug application (NDA). [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]
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]
Legislation introduced to require informed consent to administer antipsychotics to dementia patients
30 May 2012, 12:13 pm
Senators Chuck Grassley (R-Iowa), Richard Blumenthal (D- Conn.) and Herb Kohl (D-Wis.) have introduced introducing an amendment to S. 3187, the Food and Drug Administration Safety and Innovation Act, that would require informed consent to administer antipsychotic drugs to elderly... [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]
8 Jan 2020, 9:00 pm
As part of the US Food and Drug Administration’s (FDA’s) overall reorganization of the Office of New Drugs, the former Office of Hematology and Oncology Products (OHOP), the FDA office responsible for approving cancer therapies, was recently restructured and renamed the Office of Oncologic Diseases (OOD). [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]
19 Dec 2006, 5:40 pm
...that's sort of what FDA seems to be suggesting.Aspirin, ibuprofen, acetaminophen and the other related over-the-counter drugs remain safe and effective when used as directed, the Food and Drug Administration said. [read post]
16 Feb 2008, 12:03 pm
Here's an excerpt: The Food and Drug Administration wants to allow... [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]
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]
