Learn about strategies for litigating infringement and validity of active pharmaceutical ingredient, formulation, and treatment patents in Hatch-Waxman litigation. Read now » Related Content Plaintiff's Interrogatories in Hatch-Waxman Patent Litigation...
This practice note discusses key legal and regulatory issues to evaluate, questions to ask, and documents to review in mergers, acquisitions, investments, financings, and other transactions involving pharmaceutical or biological products. Read now » Related...
This practice note provides an overview of clinical trial registration requirements and step-by-step guidance for determining whether clinical trial registration is required, who must register the clinical trial, how to register a trial, and more. Read now »...
Track settlements negotiated by the U.S. Department of Justice (DOJ) in matters involving allegations of healthcare fraud and abuse—including violations of the Anti-Kickback Statute, Physician Self-Referral Law (Stark Law), and the False Claims Act—against...
Interested in private market data? Attorneys involved in negotiating clinical trial agreements are encouraged to participate in this Private Market Data Life Sciences Survey . Qualified participants will receive a $25 gift card.* Take the survey now » ...
Learn about considerations for clinical trial sponsors seeking approval of orphan drugs in light of the exclusivity provisions of the Orphan Drug Act and tension between the interpretation of those provisions by the FDA and the courts. Read now » Related...
The curated Life Sciences Corporate Transactions Resource Kit provides easy access to Practical Guidance content addressing unique issues related to corporate transactions involving pharmaceutical, medical device, and other life sciences companies. Read now »...
Find content including trackers, practice notes, state law surveys, checklists, and templates addressing some key concepts and considerations related to setting up and managing human subjects research and clinical trials for drugs and medical devices. Read now...
Use the FDA Drug Regulatory Activity Tracker to monitor FDA regulatory activity affecting your pharmaceutical clients. This tracker features summaries and action items for attorneys including effective dates and compliance dates, deadlines for submitting comments...
This checklist discusses the applicability of the drug development safe harbor provision of the Hatch-Waxman Act that creates a broad exemption from patent infringement liability for drug-research activities. Read now » Related Content Biosimilars...
This checklist explains how to prepare a New Drug Application (NDA) or Biologics License Application (BLA) for submission to the U.S. Food and Drug Administration (FDA). The checklist covers what must be included in an NDA/BLA, how it should be formatted, and how...
This checklist covers FDA medical device facility registration and medical device listing requirements. Failure to register and list with the FDA may render a device misbranded, adulterated, or both. In addition, failure to register a facility and list a medical...
This practice note outlines key considerations for attorneys who negotiate and draft research and development agreements (RDAs) for clients in the life sciences industry. RDAs typically involve two or more collaborators combining expertise to undertake mutually...
This checklist guides attorneys through drafting and submitting a controlled correspondence to the U.S. Food and Drug Administration (FDA). Controlled correspondence is correspondence submitted to the FDA, by or on behalf of a generic drug manufacturer or related...
This checklist outlines key considerations for recalls of medical device products regulated by the U.S. Food and Drug Administration (FDA). Read now » Related Content Pharmaceutical Manufacturing and Supply Chains Understand the registration of pharmaceutical...