Public health matters.

Monitor FDA approval and regulatory developments

• Monitor FDA guidance & regulations, FDA warning letters, FDCA and PDUFA with the FDA Drug Regulatory Activity Tracker, FDA Medical Device Regulatory Activity Tracker and FDA Warning Letters Tracker.
• Navigate FDA registration and DSCSA requirements for product classifications of medical devices with the FDA Regulation of Medical Devices and Pharmaceutical Manufacturing and Supply Chains practice notes.
• Harness life science and pharma law resources, including statutory and administrative agency content with alerts, international primary law and the Life Sciences/Pharmaceutical Practice Center.
• Compare state laws on licensing for pharmacists and pharmacies with the Life Sciences section of the State Law Comparison Tool.

Oversee legal aspects of clinical trials

• Review key concepts for human subject research and clinical trials with the Clinical Trials Resource Kit.
• Negotiate and draft clinical trial agreements and informed consent forms using the Clinical Trial Agreement Considerations for Pharmaceutical Sponsors practice note and Informed Consent for Clinical Trials Form  template.
• Understand state laws relating to clinical research trials with the Clinical Research State Law Survey.

Look around the corner

• Provide strategic direction for outside counsel with integrated Litigation Analytics.
• Monitor the industry landscape and anticipate shifts with legal news and analysis from Law360^® and regulatory insights and reports from MLex^®.

Leverage AI solutions

• Quickly answer questions about complex life science legal obligations.
• Draft sample clauses using life science content from Practical Guidance.
• Establish guidelines for the appropriate use of AI in the workplace with the Artificial Intelligence (AI) Driven Tools in the Workplace Policy  template.
• Stay ahead of emerging AI legal issues with the Artificial Intelligence Key Legal Issues practice note.