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...
Clinical trial sponsors often underestimate the importance of spending appropriate time and resources on clinical trial agreements (CTAs). This practice note focuses on key CTA provisions that, if overlooked, can be very costly for organizations. Read now »...
Learn about consulting agreements in the pharmaceutical industry, including types of consultants, the nature and scope of the consulting relationship, and key contractual provisions for outside consultants. Read now » Related Content 340B Drug Pricing...
Learn about the litigation process set up by the Biologics Price Competition and Innovation Act (BPCIA) to facilitate resolution of patent disputes between reference product sponsors and biosimilar manufacturers. Read now » Related Content Marketing...
By: Chad A. Landmon and Suzanne E. Bassett , POLSINELLI PC THIS ARTICLE PROVIDES GUIDANCE ON THE IMPACT of the U.S. Supreme Court’s recent decisions in Loper Bright 1 and Corner Post 2 on decision-making by the U.S. Food and Drug Administration (FDA). ...
Life sciences attorneys must understand the PTO’s duty of candor and good faith because failure to satisfy the duty can have dire consequences, including a holding of patent unenforceability. This practice note includes practical guidance for complying with...
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...