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 »...
Check out our practice note providing guidance on challenging adverse Food and Drug Administration (FDA) administrative decisions. Among other things, the practice note includes strategies for obtaining a final agency decision that can be challenged in court, overcoming...
This practice note discusses clinical hold orders issued by the U.S. Food and Drug Administration (FDA) to sponsors of investigational new drug (IND) applications, including grounds for issuing a clinical hold order, how the FDA issues an order, and how a sponsor...
Find critical content on patent protection and licensing topics for pharmaceutical, medical device, biotechnology, and other life sciences products. This resource kit includes practice notes, checklists, and templates. Read now » Related Content Hatch...
This practice note discusses key legal and regulatory issues, questions to ask, and documents to review in due diligence for drug company transactions. Read now » Related Content Alternative Dispute Resolution Provisions in Life Sciences Agreements...