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3 Apr 2024, 10:00 pm
The US Food and Drug Administration (FDA) released a draft guidance on April 3 providing recommendations to sponsors and testing sites on data integrity for bioavailability and bioequivalence (BA/BE) studies. [read post]
3 Apr 2024, 10:00 pm
The US Food and Drug Administration (FDA) released a draft guidance on April 3 providing recommendations to sponsors and testing sites on data integrity for bioavailability and bioequivalence (BA/BE) studies. [read post]
3 Apr 2024, 12:00 am
It has been approved by the Food and Drug Administration (FDA) for pain relief and anesthesia. [read post]
2 Apr 2024, 9:02 pm
The Food and Drug Administration continues using import alerts to enforce U.S. food safety regulations for food from foreign countries. [read post]
2 Apr 2024, 2:56 pm
Food and Drug Administration. [read post]
2 Apr 2024, 12:56 pm
Janet Woodcock, director of the Center for Drug Evaluation and Research at the Food and Drug Administration, “estimated that as much as 75 per cent of published biomarker associations are not replicable. [read post]
2 Apr 2024, 11:09 am
That Justice Jackson later turned that whole line of attack around (pointing out that the courts are a heck of a lot more fallible than the Food and Drug Administration when it comes to understanding drugs) was nicely done, but it should not have been necessary.We have finally reached the point where one cannot tell whether a snide remark was made in a Twitter post, on a TV show, in House or Senate hearings, or in the Supreme Court itself. [read post]
2 Apr 2024, 9:50 am
If doctors who believe the Food & Drug Administration mistakenly approved or deregulated a drug cannot sue the FDA, can anyone else? [read post]
2 Apr 2024, 9:13 am
The United States Food and Drug Administration (FDA) has proposed a rule on “Drug Products or Categories of Drug Products that Present Demonstrable Difficulties for Compounding Under sections 503A or 503B of the Federal Food, Drug, and Cosmetic Act”. [read post]
2 Apr 2024, 6:23 am
” US Food and Drug Administration (1981). [read post]
2 Apr 2024, 4:00 am
The Food and Drug Administration is assuring everyone that it has stockpiles of vaccine for highly pathogenic avian influenza A [i.e., A(HPAI)]. [read post]
1 Apr 2024, 9:05 pm
CDC works closely with state and federal agencies, including USDA, the Food and Drug Administration (FDA), and local health authorities to further investigate and closely monitor this situation. [read post]
1 Apr 2024, 9:01 pm
” The White House intends the Strike Force to focus on “key sectors . . . including prescription drugs and health care, food and grocery, housing, [and] financial services,” with the goals of lowering costs and promoting competition. [read post]
1 Apr 2024, 4:22 am
According to the details posted online by the Food and Drugs Administration (FDA), the recall was initiated on March 6, 2024, and is ongoing. [read post]
31 Mar 2024, 10:00 pm
The US Food and Drug Administration (FDA) recently issued draft guidance with recommendations to help clinical trial sponsors determine when a data monitoring committee (DMC) would be beneficial for managing clinical trials and what procedures and practices they should consider when using a DMC, significantly revising past guidance from FDA. [read post]
31 Mar 2024, 10:00 pm
The US Food and Drug Administration (FDA) recently issued draft guidance with recommendations to help clinical trial sponsors determine when a data monitoring committee (DMC) would be beneficial for managing clinical trials and what procedures and practices they should consider when using a DMC, significantly revising past guidance from FDA. [read post]
31 Mar 2024, 10:00 pm
The US Food and Drug Administration (FDA) recently issued draft guidance with recommendations to help clinical trial sponsors determine when a data monitoring committee (DMC) would be beneficial for managing clinical trials and what procedures and practices they should consider when using a DMC, significantly revising past guidance from FDA. [read post]
31 Mar 2024, 10:00 pm
The US Food and Drug Administration (FDA) recently issued draft guidance with recommendations to help clinical trial sponsors determine when a data monitoring committee (DMC) would be beneficial for managing clinical trials and what procedures and practices they should consider when using a DMC, significantly revising past guidance from FDA. [read post]
31 Mar 2024, 10:00 pm
The US Food and Drug Administration (FDA) recently issued draft guidance with recommendations to help clinical trial sponsors determine when a data monitoring committee (DMC) would be beneficial for managing clinical trials and what procedures and practices they should consider when using a DMC, significantly revising past guidance from FDA. [read post]
31 Mar 2024, 10:00 pm
The US Food and Drug Administration (FDA) recently issued draft guidance with recommendations to help clinical trial sponsors determine when a data monitoring committee (DMC) would be beneficial for managing clinical trials and what procedures and practices they should consider when using a DMC, significantly revising past guidance from FDA. [read post]
