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...
This state law survey summarizes the legal landscape across the 50 U.S. states and the District of Columbia surrounding Food, Drug, and Cosmetic Act (FDCA)-based failure-to-warn claims predicated on violations of the reporting requirements of the FDCA. It identifies...
Understand preemptive steps for maximizing a pharmaceutical product's regulatory and patent exclusivities and the chances of success in future patent litigation against generic drug applicants. Read now » Related Content Life Sciences Patents...
Understand key provisions of life sciences licensing agreement term sheets, including fields of use, retained rights and government rights, diligence milestones, and royalties. This practice note also covers business issues to consider when advising your client...
This practice note explains the legal and regulatory scheme for recalls of pharmaceuticals and medical devices, including the role of the FDA, and includes practical tips for conducting a recall. Read now » Related Content FDA Warning Letters Tracker...
See this practice note for a discussion of adverse drug event reporting responsibilities in the pharmaceutical industry. The note provides guidance on creating a framework for compliance with U.S. Food and Drug Administration (FDA) requirements. Read now »...