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18 Aug 2024, 10:00 pm
Recognizing the importance of diversity and inclusivity in clinical trials, drug development, and regulatory decision-making, Congress amended the Federal Food, Drug, and Cosmetic Act (FDCA) in connection with the Food and Drug Omnibus Reform Act (FDORA) provisions of the Consolidated Appropriations Act of 2023, requiring sponsors of certain clinical studies of drugs, biological products, and medical devices to submit Diversity Action Plans to the FDA (FDCA Sections 505(z) and 520(g)(9)). [read post]
18 Aug 2024, 10:00 pm
Recognizing the importance of diversity and inclusivity in clinical trials, drug development, and regulatory decision-making, Congress amended the Federal Food, Drug, and Cosmetic Act (FDCA) in connection with the Food and Drug Omnibus Reform Act (FDORA) provisions of the Consolidated Appropriations Act of 2023, requiring sponsors of certain clinical studies of drugs, biological products, and medical devices to submit Diversity Action Plans to the FDA (FDCA Sections 505(z) and 520(g)(9)). [read post]
18 Aug 2024, 10:00 pm
Recognizing the importance of diversity and inclusivity in clinical trials, drug development, and regulatory decision-making, Congress amended the Federal Food, Drug, and Cosmetic Act (FDCA) in connection with the Food and Drug Omnibus Reform Act (FDORA) provisions of the Consolidated Appropriations Act of 2023, requiring sponsors of certain clinical studies of drugs, biological products, and medical devices to submit Diversity Action Plans to the FDA (FDCA Sections 505(z) and 520(g)(9)). [read post]
18 Aug 2024, 9:06 pm
Many people recover in a week, but Campylobacter infection can result in long-term consequences, such as arthritis, irritable bowel syndrome (IBS), and Guillain-Barré syndrome (GBS). [read post]
18 Aug 2024, 9:06 pm
By Dr Benjamin HaywardAssociate Professor, Department of Business Law and Taxation, Monash Business SchoolX: @LawGuyPI, @MonashITICL On 7 August 2024, the High Court of Australia handed down its long-awaited decision in Tesseract International Pty Ltd v Pascale Construction Pty Ltd [2024] HCA 24. [read post]
18 Aug 2024, 9:05 pm
Even where survival is not an issue, doing so may still provide a competitive advantage, boosting the firm’s potential for long-term profits. [read post]
18 Aug 2024, 6:31 pm
However, a California judge allowed new DNA testing on only one item: a 15.5-inch-long piece of duct tape found on Laci Peterson’s pants. [read post]
18 Aug 2024, 6:31 pm
However, a California judge allowed new DNA testing on only one item: a 15.5-inch-long piece of duct tape found on Laci Peterson’s pants. [read post]
18 Aug 2024, 6:31 pm
However, a California judge allowed new DNA testing on only one item: a 15.5-inch-long piece of duct tape found on Laci Peterson’s pants. [read post]
18 Aug 2024, 6:31 pm
However, a California judge allowed new DNA testing on only one item: a 15.5-inch-long piece of duct tape found on Laci Peterson’s pants. [read post]
18 Aug 2024, 6:31 pm
However, a California judge allowed new DNA testing on only one item: a 15.5-inch-long piece of duct tape found on Laci Peterson’s pants. [read post]
18 Aug 2024, 6:31 pm
However, a California judge allowed new DNA testing on only one item: a 15.5-inch-long piece of duct tape found on Laci Peterson’s pants. [read post]
18 Aug 2024, 5:53 pm
We have had multiple clients who have had to guess what to submit because the De Novo summary was not available, even though the De Novo had been granted long before. [read post]
18 Aug 2024, 4:08 pm
At the end of the long season, the players with the most points get to say which eligible charities get the money in the pool. [read post]
18 Aug 2024, 2:52 pm
Federal courts have upheld government limitations on lawful assembly so long as the content or messaging of a protest is unaffected by the regulations. [read post]
18 Aug 2024, 2:45 pm
18 Aug 2024, 2:40 pm
News articles and public statements reflect that the Campaign has long prepared for President Biden’s exit from the race. [read post]
18 Aug 2024, 2:10 pm
In a statement on Friday, Comer said: Americans should be deeply concerned that Governor Walz, Kamala Harris’s vice-presidential running mate, has a long-standing and cozy relationship with China, Mr. [read post]
18 Aug 2024, 11:46 am
He found that then-President Donald Trump’s pardon of the wire fraud conviction came long after a final adjudication of the case and could not qualify as a “successful defense of the charges. [read post]
18 Aug 2024, 11:38 am
Identifying mandatory contract provisions for a residential contract of sale is not hard; it is not like trigonometry but more like long division. [read post]