Posts tagged with: "fda"
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25 Mar 2024, 10:00 pm
Spurred by a March 5, 2024 citizen petition to the Food and Drug Administration (FDA), a flurry of class action complaints have been filed claiming that drug makers failed to warn consumers about the presence of benzene in popular acne products. [read post]
25 Mar 2024, 10:00 pm
Spurred by a March 5, 2024 citizen petition to the Food and Drug Administration (FDA), a flurry of class action complaints have been filed claiming that drug makers failed to warn consumers about the presence of benzene in popular acne products. [read post]
25 Mar 2024, 6:38 pm
“What’s at stake in the Supreme Court abortion pill case; Tuesday’s oral argument is focused on whether to overrule the FDA and reimpose some restrictions on getting medication to terminate pregnancy”: Ann E. [read post]
25 Mar 2024, 12:39 pm
Both the FDA and Danco went to the U.S. [read post]
25 Mar 2024, 7:55 am
The Fifth Circuit overturned FDA’s finding that the pills’ use under those conditions was “safe and effective. [read post]
25 Mar 2024, 7:17 am
Food and Drug Administration (FDA) recognizes these risks. [read post]
25 Mar 2024, 7:17 am
Food and Drug Administration (FDA) recognizes these risks. [read post]
25 Mar 2024, 7:17 am
Food and Drug Administration (FDA) recognizes these risks. [read post]
25 Mar 2024, 7:00 am
Under Central Hudson, the FDA lacked even “a shred of evidence ... showing that the graphic warnings will ‘directly advance’ [FDA’s] interest in reducing the number of Americans who smoke. [read post]
25 Mar 2024, 4:10 am
While 26 million nicotine alternative products submitted PMTAs to the FDA, only 23 have been approved. [read post]
25 Mar 2024, 4:00 am
His decision would have allowed virtually anyone to object to FDA approval of any drug, for any reason. [read post]
25 Mar 2024, 12:00 am
FDA Warnings and Drug Liability When the U.S. [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The US Food and Drug Administration (FDA) issued draft guidance, providing recommendations to sponsors who are considering submitting a non-interventional study (i.e., an observational study) to FDA to support the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The US Food and Drug Administration (FDA) issued draft guidance, providing recommendations to sponsors who are considering submitting a non-interventional study (i.e., an observational study) to FDA to support the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
Specifically, they did not develop an FSVP for any of the foods they import: (Redacted by FDA) candy imported from (redacted by FDA), located in (redacted by FDA) (Redacted by FDA) candy imported from (redacted by FDA), located in (redacted by FDA) Cheetos Nacho chips imported from (redacted by FDA), located in (redacted by FDA) The full warning letter can be viewed here. [read post]
24 Mar 2024, 7:19 pm
Eight highlights from this week: How to Figure Out What Your Car Knows About You; The Feds Can Film Your Front Porch for 68 Days Without a Warrant, Says Court; X Continues to Break as Fraudsters Use Deceptive Links to Scam; FDA and You; Artificial Intelligence and Medical Products: How CBER, CDER, CDRH, and OCP are Working Together; DOJ sues Apple in antitrust case, says it has illegal monopoly over smartphones; Data brokers admit they’re selling information on precise location, kids,… [read post]
