This practice note helps attorneys representing drug and medical device manufacturers advise their clients about liability risks associated with their products, by summarizing the legal landscape surrounding FDCA-based failure-to-warn claims, providing a state...
Quickly identify relevant state clinical trial laws about clinical trial coverage, populations, access, and informed consent and confidentiality. Read now » Related Content Institutional Review Board Written Procedures Checklist Prepare and maintain...
This updated checklist outlines key regulatory compliance considerations for personal care products marketed in the United States. Read now » Related Content FDA Cosmetics Labeling Regulations Understand cosmetic product labeling, including misbranding...
This practice note covers the development, regulation, and reimbursement of laboratory developed tests (LDTs), which are typically used when an FDA-approved test does not exist, when FDA-approved tests are limited in availability, or when available tests do not...
Check out this video discussing best practices for responding to FDA Form 483 inspectional observations. Watch now » Related Content Life Sciences FDA Matters Representation and Warranty Clause Use this template to start drafting a compliance representation...
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...