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FDA releases priority list of food guidance documents FDA intends to publish by June 2022 | Hogan Lovells

FDA releases priority list of food guidance documents FDA intends to publish by June 2022 | Hogan Lovells
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The End of Enforcement Discretion for Cell & Gene Therapies: Thinking Through Next Steps | King & Spalding

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Beginning this week, the U.S. Food and Drug Administration (“FDA”) ended its compliance and enforcement discretion policy with regard to certain human cell, tissue, and cellular and tissue-based products (“HCT/Ps”). HCT/P manufacturers without an FDA-approved marketing application may find themselves subject to FDA scrutiny under the Federal Food, Drug, and Cosmetic Act (“FD&C Act”) and the Public Health Service Act (“PHS Act”). Firms will have to think hard about whether to submit investigational new drug applications (“INDs”) or marketing applications, wind down production, or risk running afoul of applicable laws and regulations governing unapproved biological products. They should also be mindful of how data collected to date can help to inform next steps. ....

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What Can Schools Do About Non-Title IX Sexual Misconduct?

May we? Must we? Should we? Shall we? What Can Schools Do About Non-Title IX Sexual Misconduct.
Sunday, January 17, 2021
The Title IX regulations that went into effect in August 2020 significantly narrowed the scope of conduct that the United States Department of Education Office of Civil Rights (“OCR”) defined as violating Title IX, the broad law prohibiting sex or gender discrimination in education. These regulations have the force of law.
Carved out of Title IX coverage was potentially a vast amount of sexual misconduct that could have detrimental impacts on the campus work and academic environment. The new regulations excluded from Title IX protection off-campus conduct, conduct occurring in study abroad programs, and sexual harassment of employees under Title VII which does not satisfy the new narrower definition of Title IX sexual harassment. ....

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