This practice note explains whether and how drug, medical device, biologics, and other life sciences companies should include ADR mechanisms in their contracts to resolve commercial disputes. Read now » Related Content License, Development, and Commercialization...
This practice note covers how to respond to a complete response letter issued by the FDA as part of the agency’s new drug application (NDA) or biologics license application (BLA) process. Read now » Related Content FDA Drug Regulatory Activity...
This practice note discusses FDA clinical hold orders issued to IND sponsors and covers grounds for issuing a clinical hold order, how the FDA issues an order, and how a sponsor should respond to a clinical hold order to ensure a timely review. Read now »...
This checklist covers the applicability of artificial intelligence (AI) in areas critical to life sciences and healthcare companies, including data privacy, intellectual property, and research and development. Read now » Related Content FDA Artificial...
This practice note addresses government guidance on pharmaceutical pricing, pricing in monopolistic markets, pricing in oligopolistic markets, and liability risks. Read now » Related Content Healthcare Antitrust Resource Kit Access critical content...
This practice note covers key legal and regulatory issues to evaluate, questions to ask, and documents to review in medical device or diagnostic technology deals, including M&A, investments, financings, and joint ventures. Read now » Related Content...
This practice note covers FDA prior notice requirements for imported food, including scope and exceptions, notification contents and timing, methods of submitting notice, and consequences for failing to provide proper notice. Read now » Related Content...
This practice note covers dietary supplement structure/function claims and the laws and regulations, administrative guidance, and federal cases that govern them. Read now » Related Content Dietary Supplement Label Checklist Understand general federal...
This practice note discusses Institutional Review Boards (IRBs) within the United States, including their purpose, history, and regulatory framework. The note is a valuable resource for advising life sciences and healthcare clients on IRB-related matters and ensuring...
Understand the prescription drug discount program established under Public Health Service Act Section 340B. Read now » Related Content Life Sciences Post-Closing Price Reporting Covenant Clause Use this template clause to comply with price reporting...
This checklist covers how the Hatch-Waxman safe harbor provision applies to the drug development process. Read now » Related Content Hatch-Waxman Act Fundamentals Get an overview of the approval process for prescription drugs under the Hatch-Waxman...
This practice note includes an overview of FDA medical device regulatory requirements including premarket notification and approval, investigational device exemptions, and quality system regulations. Read now » Related Content FDA Medical Devices...
This practice note highlights critical regulatory issues to evaluate, questions to ask, and documents to review in deals involving drug products. Read now » Related Content Life Sciences Due Diligence Considerations in M&A Transactions Checklist...
This state law survey covers key issues related to operating wholesale drug distributors in the 50 U.S. states and District of Columbia, including products regulated, licensing requirements, and designated representative requirements. Read now » Related...
This state law survey, covering the 50 U.S. states, the District of Columbia, and the U.S. Territories, addresses key topics related to the administration of vaccines and immunizations by pharmacists, including continuing education requirements, administration...