Posts tagged with: "fda"
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1 Apr 2024, 12:12 pm
About 27.9% of complaints filed against life sciences companies in 2023 (or 12 out of 43 complaints) involved alleged misrepresentations regarding regulatory hurdles, the timing of FDA approval, or the sufficiency of applications submitted to the FDA. [read post]
1 Apr 2024, 10:58 am
by Dennis Crouch In April 2024, the Federal Circuit issued a significant decision vacating a district court’s judgment that Janssen Pharmaceuticals’ dosing regimen patent claims were nonobvious. [read post]
1 Apr 2024, 9:00 am
appeared first on Cohen Healthcare Law Group | Healthcare Lawyers | FDA & FTC Law. [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The US Food and Drug Administration (FDA) recently issued draft guidance with recommendations to help clinical trial sponsors determine when a data monitoring committee (DMC) would be beneficial for managing clinical trials and what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The US Food and Drug Administration (FDA) recently issued draft guidance with recommendations to help clinical trial sponsors determine when a data monitoring committee (DMC) would be beneficial for managing clinical trials and what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The US Food and Drug Administration (FDA) recently issued draft guidance with recommendations to help clinical trial sponsors determine when a data monitoring committee (DMC) would be beneficial for managing clinical trials and what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The US Food and Drug Administration (FDA) recently issued draft guidance with recommendations to help clinical trial sponsors determine when a data monitoring committee (DMC) would be beneficial for managing clinical trials and what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The US Food and Drug Administration (FDA) recently issued draft guidance with recommendations to help clinical trial sponsors determine when a data monitoring committee (DMC) would be beneficial for managing clinical trials and what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]
31 Mar 2024, 9:01 pm
Specifically, they did not develop an FSVP for any foods that they import, except for the following foods: Extra hot snack mix imported from (redacted by FDA), (redacted by FDA) Shredded frozen coconut imported from (redacted by FDA), (redacted by FDA) Banana chips imported from (redacted by FDA) and (redacted by FDA), (redacted by FDA) While they provided FSVP documents for extra hot snack mix imported from (redacted by… [read post]
31 Mar 2024, 5:54 pm
FDA’s understating the number of LDTs would result in FDA understating the total costs of complying with a final rule. [read post]
29 Mar 2024, 11:20 am
”In fact, the FDA authorizes health claims only when there is “significant scientific agreement. [read post]
29 Mar 2024, 10:03 am
They sent letters to the Food and Drug Administration (the "FDA") that painstakingly analyzed published results, data, and methodology, published presentations aimed at investors that summarized the letters and analyzed Cassava's public representations, and posted hundreds of tweets, which were, by their nature, much less rigorous. [read post]
29 Mar 2024, 9:54 am
Food and Drug Administration’s (“FDA”) regulatory review framework for infant formula products. [read post]
29 Mar 2024, 7:22 am
“Does Any Party Have Standing to Challenge FDA Drug Approvals? [read post]
29 Mar 2024, 6:44 am
According to the details posted online by the Food and Drugs Administration (FDA), the recall was initiated on Feb. 22, 2024, and is ongoing. [read post]
29 Mar 2024, 5:52 am
Food and Drug Administration (FDA), and the U.S. [read post]
29 Mar 2024, 5:52 am
Food and Drug Administration (FDA), and the U.S. [read post]
29 Mar 2024, 5:52 am
Food and Drug Administration (FDA), and the U.S. [read post]
