Learn best practices for advocating on behalf of your FDA-regulated clients in light of the new legal paradigm introduced by the Supreme Court’s decisions in Loper Bright and Corner Post . Read now » Related Content Life Sciences Regulatory...
Draft an agreement with a research institution to perform clinical research on behalf of a manufacturer. This template includes helpful drafting notes and alternate clauses. Related Content Institutional Review Board (IRB) Formation, Organization, and Operation...
Identify critical issues related to establishing quality standards in a pharmaceutical supply or manufacturing agreement. Read now » Related Content FDA Warning Letters Tracker Monitor trends in FDA enforcement activity affecting life sciences clients...
Understand how to prepare and submit a request to the FDA asking it to review critical elements of a protocol design. Read now » Related Content FDA Drug Regulatory Activity Tracker Follow new FDA regulatory activity affecting drug products and identify...
Determine whether a corporation, partnership, association, or individual pursuing a drug product application or holding an approved drug product application has violated the FDA Debarment Act, potential penalties, and certification requirements. Read now »...
Check out this template designed for non-emergency use of an investigational drug to treat a patient under FDA expanded access investigational new drug regulations. Read now » Related Content Right-to-Try and Expanded Access to Experimental Drugs...
Review general labeling requirements for dietary supplements marketed in the United States with this helpful checklist. Read now » Related Content FDA Food and Dietary Supplements Regulatory Activity Tracker Monitor Food and Drug Administration (FDA...
Use this 50-state (plus the District of Columbia and U.S. Territories) survey to research state clinical research regulations, with a focus on clinical trial coverage, populations, access, and informed consent and confidentiality. Read now » Related Content...
Understand the role of ADR mechanisms in drug, medical device, biologics, and other life sciences agreements. Read now » Related Content Life Sciences Due Diligence Considerations in M&A Transactions Checklist Identify key due diligence considerations...
Access practice notes, checklists, and other essential content and tools covering labeling requirements for FDA-regulated products with the Life Sciences Labeling, Marketing, and Sales Resource Kit. Read now » Related Content FDA Warning Letters Tracker...
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...