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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The US Food and Drug Administration (FDA) issued draft guidance, providing recommendations to sponsors who are considering submitting a non-interventional study (i.e., an observational study) to FDA to support the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]
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The US Food and Drug Administration (FDA) issued draft guidance, providing recommendations to sponsors who are considering submitting a non-interventional study (i.e., an observational study) to FDA to support the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]
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The US Food and Drug Administration (FDA) issued draft guidance, providing recommendations to sponsors who are considering submitting a non-interventional study (i.e., an observational study) to FDA to support the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]
24 Mar 2024, 9:03 pm
As part of its enforcement activities, the Food and Drug Administration sends warning letters to entities under its jurisdiction. [read post]
24 Mar 2024, 5:36 pm
Under this law, manufacturers may not deny contract pharmacies access to a covered entity’s 340B drugs, or deny 340B drug pricing to covered entities who use contract pharmacies for distribution. [read post]
22 Mar 2024, 1:27 pm
Two gentlemen in California are arrested with a bunch of drugs and a bunch of guns, respectively. [read post]
22 Mar 2024, 7:12 am
Food and Drug Administration (FDA) has recently identified several brands of eye drops that were sold with contaminants. [read post]
22 Mar 2024, 7:12 am
Food and Drug Administration (FDA) has recently identified several brands of eye drops that were sold with contaminants. [read post]
22 Mar 2024, 7:12 am
Food and Drug Administration (FDA) has recently identified several brands of eye drops that were sold with contaminants. [read post]
21 Mar 2024, 9:05 pm
And remember to follow the advice of the Federal Food and Drug Administration (FDA) and wash your fruits and vegetables. [read post]
19 Mar 2024, 9:00 pm
The Food and Drug Administration continues using import alerts to enforce U.S. food safety regulations for food from foreign countries. [read post]
19 Mar 2024, 5:00 am
Food and Drug Administration (FDA) for post-traumatic stress disorder (PTSD) means the drug may be rescheduled, which will lead to substantially decreased regulations attached to it. [read post]
19 Mar 2024, 4:00 am
At issue are challenges to the Food and Drug Administration's relaxation of restrictions on the administration and use of the abortion drug mifepristone. [read post]
18 Mar 2024, 9:30 pm
They explain:On March 26, Food and Drug Administration v. [read post]
18 Mar 2024, 9:30 am
This post provides a brief update.On March 26, Food and Drug Administration v. [read post]
18 Mar 2024, 6:55 am
Food and Drug Administration (FDA), Exactech has recalled hundreds of thousands of defective medical implant devices sold between 2004 and 2021. [read post]
18 Mar 2024, 6:55 am
Food and Drug Administration (FDA), Exactech has recalled hundreds of thousands of defective medical implant devices sold between 2004 and 2021. [read post]
18 Mar 2024, 6:55 am
Food and Drug Administration (FDA), Exactech has recalled hundreds of thousands of defective medical implant devices sold between 2004 and 2021. [read post]
17 Mar 2024, 9:05 pm
The justices are being asked to countermand scientific judgments made by the Food and Drug Administration in revising dispensing requirements for mifepristone, a medicine used to induce an abortion. [read post]
17 Mar 2024, 9:01 pm
As part of its enforcement activities, the Food and Drug Administration sends warning letters to entities under its jurisdiction. [read post]
