The Industry Edge: Global Life Sciences Digest

FDA Articulates High Benefit-Risk Expectations For Drug Developers

The U.S. Food and Drug Administration (FDA) is soliciting comments on significant new draft guidance for companies engaged in drug development. The draft provides recommendations on the use of patient experience data in new drug applications (NDAs) and biologics license applications (BLAs) and sets forth high expectations for generation of evidence on both benefits and risks, including in rare diseases.

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In This Issue

Data Privacy

If Your Company Is GDPR Compliant, Are You Ready for China’s PIPL?
Regulatory Updates

Shortages of Medicinal Products Tackled by EU Regulators
Global Drug Pricing

U.S. Looks to Introduce European-Style Drug Price Controls
Regulatory Updates

Four Ways FDA’s New Intended Use Regulations Affect Drug and Medical Device Companies
Data Privacy

How To Minimize FCA Cyberfraud Enforcement Risk
Events

Webinar Series: How the Green Wave Is Set to Reshape Chemical and Consumer Product Regulations Globally
Global Drug Pricing

Global Drug Pricing Resource Page
Digital Health

Regulators Offer Fresh Guidance on Using Real-World Data to Support Regulatory Decisions
Events

FDA’s Intended Use Final Rule: Constitutional Implications and Practical Consequences
Digital Health

How Artificial Intelligence Manufacturers Can Protect Themselves Against Future Negligence Claims
Regulatory Updates

Five Ways FDA’s New Final Rule on Intended Use Could Affect Consumer Products
Regulatory Updates

HHS Announces Withdrawal of Good Guidance Practices and Fairness in Enforcement Rules
Regulatory Updates

U.S. Agencies Issue Regulations on No Surprises Act’s Independent Dispute Resolution Process and Good Faith Estimate Requirements
Events

Implications of FDA’s Final Rule on Intended Use on Safe-Harbored Communications
Data Privacy

Switzerland Recognizes New EU Standard Contractual Clauses and Issues Guidance on International Data Transfers
Digital Health

Pharmacovigilance Considerations in the Era of Patient Centricity: Data Collected by Apps
Events

6th Annual Bay Area Lifesciences Roundtable
Global Drug Pricing

Medicare “Most Favored Nation” Drug Payment Heading to Rescission, Shifting Focus to Potential Alternatives
Digital Health

Singapore to License Telemedicine Service Providers from 2022

The Sidley Podcast

Increased Scrutiny Has Boards of Directors in the Hot Seat

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The Sidley Podcast

How to Mitigate Corporate Risk and Respond to Crises

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Contacts

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