Tag Archives: Guidance

Potential Major Changes in Updated Draft Pre-Sub Guidance

By Allyson B. Mullen — By far one of CDRH’s greatest recent successes has been the Pre-Submission program. In our experience, more companies have been engaging early and often with the Agency to discuss product-related regulatory issues and questions. Under … Continue reading

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FSB guidance on bail-in execution and resolution funding

The Financial Stability Board (FSB) has published two guidance documents to assist authorities in implementing its Key Attributes of Effective Resolution Regimes (Key Attributes) for global systemically important banks (G-SIBs): Principles on Bail-in Execution – the Key Attributes require FSB … Continue reading

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FDA Issues First Installment of Guidance on Intentional Adulteration Rule

By Riëtte van Laack — The FSMA final rule on intentional adulteration, entitled “Mitigation Strategies to Protect Food against Intentional Adulteration” (IA rule), 21 C.F.R. Part 121, was published in May, 2016. The rule is designed to address hazards that … Continue reading

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NLRB General Counsel Issues Post-Boeing Guidance Memorandum On Employer Handbook Rules

On June 6, 2018, National Labor Relations Board (“NLRB”) General Counsel Peter B. Robb issued a memorandum (“GC 18-04”) to NLRB Regional Directors providing guidance on how to analyze employee handbook rules in the wake of the Board’s recent decision … Continue reading

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SEC Guidance on Cybersecurity Disclosure and Policies – Recap of Dorsey Webinar Presentation

Earlier this week, Dorsey hosted a webinar panel presentation on the SEC’s recent guidance on cybersecurity disclosures and policies. The webinar provided a detailed walk-through of the SEC’s guidance, including issues related to enhanced disclosure, insider trading, and Reg FD policies. … Continue reading

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