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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The US Food and Drug Administration (FDA) issued draft guidance, providing recommendations to sponsors who are considering submitting a non-interventional study (i.e., an observational study) to FDA to support the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The US Food and Drug Administration (FDA) issued draft guidance, providing recommendations to sponsors who are considering submitting a non-interventional study (i.e., an observational study) to FDA to support the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, 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
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
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]
20 Mar 2024, 9:05 pm
Food and Drug Administration at the federal level. [read post]
20 Mar 2024, 9:00 am
On March 5, 2024, the Food and Drug Administration (FDA) issued its “Dietary Supplements: New Dietary Ingredient Notification Procedures and Timeframes: Guidance for Industry” (“Final Guidance”). [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, 3:04 pm
The Food and Drug Administration as well as most state and local public health officials across the country advise against consuming unpasteurized, raw milk because it is often contaminated with bacteria such as Listeria, E. coli, Salmonella and Campylobacter. [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
Supreme Court will hear oral arguments in Food and Drug Administration v. [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]
