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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, 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, 9:01 pm
Inadequate HACCP plan implementation: The HACCP plan provided by Jolca, S.A. lacked critical components such as critical limits, monitoring procedures, monitoring records and verification procedures for the identified critical control points. [read post]
18 Aug 2024, 7:38 pm
Continue reading No Concrete Plans, No Standing: Federal Circuit’s Latest on IPR Appeals at Patently-O. [read post]
18 Aug 2024, 7:20 pm
There was also the suspension of American Healthcare REIT’s share repurchase plan in 2022 (barring requests related to qualifying disability or death). [read post]
18 Aug 2024, 6:00 pm
The IRS last month clarified this issue and announced how it plans to apply the 10 year rule. [read post]
18 Aug 2024, 5:43 pm
This includes creating emergency shelters that are pet-friendly and incorporating animals into evacuation plans. [read post]
18 Aug 2024, 5:40 pm
This includes creating emergency shelters that are pet-friendly and incorporating animals into evacuation plans. [read post]
18 Aug 2024, 4:47 pm
With careful planning and the help of a skilled estate planning attorney, you can navigate the complexities of estate planning and find peace of mind. [read post]
18 Aug 2024, 11:38 am
Seventh, a notice that the property may be subject to a development plan is required, which notice includes information on where a development plan may be viewed. [read post]
18 Aug 2024, 9:38 am
This subsidy plan does nothing for them. [read post]
18 Aug 2024, 9:35 am
"Do you plan to double-dip by taking both a pension and your salary as attorney general? [read post]
18 Aug 2024, 8:00 am
” Washington Post Equity and Justice Related Articles & Resources: This is exactly how Project 2025 plans to gut DEI (Pavithra Mohan, Fast Company) The Strange Report Fueling the War on Trans Kids (Lydia Polgreen, NY Times) Asian American Voters Could Be Key Swing Voters of 2024 (Amy Qin, NY Times) Climate Change Articles & Resources: 9 Things Musk and Trump Said About Climate Change, Annotated (Brad Plumer and Raymond Zhong, NY Times) Opinion: I’m a… [read post]
18 Aug 2024, 6:30 am
Companies with strong performance, refreshed Board of Directors, and a track record of operational improvements demonstrated that proactive governance actions accompanied by strong execution of a strategic plan can be successful in a contested situation involving an activist. [read post]
18 Aug 2024, 6:30 am
"A mobile health center run by Planned Parenthood Great Rivers, which serves much of Missouri and part of southern Illinois, plans to park itself near the convention and offer those services early next week to anybody who makes an appointment, delegate or not. [read post]
18 Aug 2024, 6:30 am
Companies with strong performance, refreshed Board of Directors, and a track record of operational improvements demonstrated that proactive governance actions accompanied by strong execution of a strategic plan can be successful in a contested situation involving an activist. [read post]
18 Aug 2024, 6:11 am
The new statute also prohibits a requirement for review and approval of plans and specifications for a central air conditioning, refrigeration, heating, or ventilating system if such system is not visible from the parcel’s frontage, an adjacent parcel, an adjacent common area, or a community golf course and is substantially similar to a system that is approved or recommended by the association or a committee thereof. [read post]
