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Corporate

FDA Product Testing and Clinical Research

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During the early stages of FDA approval process, we work with you and the FDA to ascertain the nature and quantity of pre-clinical and clinical data required for your particular marketing application. In addition, we provide you with guidance on chemistry manufacturing and controls, bioavailability and bioequivalence issues, physical testing, and software design and validation.

We recognize that clinical testing is traditionally the largest expense of an the FDA filing, making the proper interpretation of FDA guidelines critical to your product development process. Our attorneys can help:

  • Provide strategic and tactical level advice on the development, assessment, structuring, and implementation of clinical research programs and research institutes in academic and traditionally non-academic settings
  • Prepare, advise, and shepherd all types of applications through the FDA approval process, including investigational new drug (IND) applications, new drug applications (NDA), abbreviated new drug applications (ANDA), investigational device exemption (IDE) applications, 510(k) applications, pre-market applications (PMA), and investigator/sponsored initiatives 
  • Defend and negotiate resolution or corrective action plans for on-site inspections conducted — and sanction actions imposed — by the FDA and other regulatory agencies 
  • Develop and implement FDA compliance programs with respect to Good Clinical Practice guidelines, federal-wide assurances, research protocols, informed consent, conflicts of interest, adverse event reporting, and research policies and procedures
  • Structure plans for and advise institutional review boards (IRBs) — both community-based and commercial — on compliance with FDA regulations
  • Structure and implement collaborative clinical research arrangements among multiple institutions, IRBs, and principal investigators
  • Negotiate and draft clinical research agreements
  • Negotiate issues related to the import or export of clinical research test articles with U.S. Customs and Border Protection (CBP) and the FDA
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