Understand the parameters of non-patent marketing exclusivities for prescription drugs in the United States. Read now » Related Content Hatch-Waxman Safe Harbor Checklist Refer to this checklist when advising pharmaceutical companies about conducting...
Find essential Practical Guidance resources for understanding key concepts and considerations related to setting up and managing human subjects research and clinical trials for drugs and medical devices. Read now » Related Content HIPAA Authorization...
Learn how to contest adverse FDA administrative decisions, with strategies for obtaining a final agency decision that can be challenged in court, overcoming agency deference challenges, and selecting a jurisdiction. READ NOW » Related Content FDA...
Bookmark the FDA Warning Letters Tracker, set an Alert, and Stay Informed! Review FDA warning letters issued by the FDA for violations (or potential violations) of the FDCA, FDA regulations, or agency guidance by industry competitors, and identify FDA enforcement...
This practice note explains the FDA's regulatory framework for artificial intelligence/machine learning (AI/ML) devices and the FDA's Final Guidance on clinical decision support (CDS) software. Read now » Related Content Five Tips for Bringing...
Check out this practice note for guidance on effectively responding to Form 483 inspectional observations issued by an FDA investigator following a facility inspection. Read now » Related Content FDA Form 483 Inspectional Observations: Best Practices...
This resource kit provides quick access to essential content and tools for advising your life sciences clients that are subject to oversight and enforcement actions by very active federal and state administrative agencies, including the FDA. Read now »...
Understand the 340B prescription drug discount program and critical issues for eligible hospitals, federally qualified health centers, and other healthcare organizations. Read now » Related Content Navigating Uncertainties in the 340B Drug Pricing...
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 »...