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25 Mar 2024, 12:39 pm by Amy Howe
It was first approved by the Food and Drug Administration in 2000 as part of a two-drug protocol (along with the drug misoprostol) to end pregnancies in their early stages. [read post]
25 Mar 2024, 4:00 am by Eric Segall
Here is a summary based on their work:Most women seeking to terminate their pregnancies now use medication--a protocol that starts with mifepristone, which the Food and Drug Administration approved 24 years ago. [read post]
25 Mar 2024, 12:00 am
Food and Drug Administration (FDA) approves a drug for consumer use, pharmaceutical companies have a duty to provide proper warnings about potential risks and side effects. [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The US Food and Drug Administration (FDA) issued draft guidance, providing recommendations to sponsors who are considering submitting a non-interventional study (i.e., an observational study) to FDA to support the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The US Food and Drug Administration (FDA) issued draft guidance, providing recommendations to sponsors who are considering submitting a non-interventional study (i.e., an observational study) to FDA to support the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, 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The US Food and Drug Administration (FDA) issued draft guidance, providing recommendations to sponsors who are considering submitting a non-interventional study (i.e., an observational study) to FDA to support the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The US Food and Drug Administration (FDA) issued draft guidance, providing recommendations to sponsors who are considering submitting a non-interventional study (i.e., an observational study) to FDA to support the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, 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 by News Desk
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 by Kurt R. Karst
Act 1103 Does Not Make it Impossible for Drugmakers to Comply with the FDCA PhRMA also argued that Act 1103 is preempted by the Federal Food, Drug, and Cosmetic Act through impossibility preemption. [read post]
22 Mar 2024, 1:27 pm by John Ross
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 by SearcyLaw
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 by SearcyLaw
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 by SearcyLaw
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 by Coral Beach
 And remember to follow the advice of the Federal Food and Drug Administration (FDA) and wash your fruits and vegetables. [read post]