At the beginning of the FDA approval process, Bryan Cave attorneys provide an assessment of the most effective pathway to approval. Not only do we interact with clients and FDA to ascertain the nature and quantity of pre-clinical and clinical data that a particular marketing application will require, but we also provide guidance on chemistry manufacturing and controls, bioavailability and bioequivalence issues, physical testing, and software design and validation. A review of this nature requires extensive experience interpreting FDA guidelines and is critical for successful and cost-effective product development because clinical testing is typically the largest expense of an FDA filing.
In the areas of clinical research and new medical innovations, our attorneys can help:
- Provide strategic- and tactical-level advice on the development, assessment, structuring, and implementation of clinical research programs in both academic and non-academic programs
- Negotiate international clinical trial agreements and protocols, ensuring that the results are consistent with FDA requirements
- Prepare, advise, and manage various applications through the FDA approval process, including investigational new drug (IND) applications, abbreviated drug applications, investigational device exemption (IDE) applications, 510(k) applications, pre-market applications (PMA), and investigator/sponsored initiatives
- Develop corrective action plans for on-site audits conducted and sanction actions imposed by 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 FDA