Regulatory Affairs

Jurisdiction: Chimera assists clients on product jurisdiction by developing strategies and assisting in drafting Request for Designation (RFD) Applications. Chimera can facilitate formal or informal consultations with FDA Centers and with the Office of Combination Products in jurisdictional determinations and disputes.

Applications/submissions: Chimera advises clients on strategies for efficient development through the submission of investigational exemption applications (i.e., IND, IDE) and/or achieving market clearance or approval through the submission of marketing applications [i.e., 505(b)(1) and 505(b)(2) NDA, BLA, 510(k), PMA]. How applications are structured significant implications for the effective management of downstream issues such as the submission of safety reports and post-marketing manufacturing changes to applications. Sometimes a single application is most appropriate and in other cases multiple applications are better. Chimera assists clients in establishing a circumspect submissions strategy, drafting submissions, or by reviewing client-generated submissions and supporting documentation, including Drug Master Files and Device Master Files. Chimera can also draft CMC modules, module sections and master files that support investigational exemption applications and marketing applications. .

Manufacturing and Design Changes: As medical products mature throughout their life-cycle, typically designs evolve and manufacturing processes are refined. Chimera advises clients on effective strategies for reporting change marketing applications and notifications. The rules for reporting changes to drug, biologic and medical device applications are all different. Applying these rules when a drug, biologic or device is a constituent of a combination product is complex. How the marketing application was originally structured will impact how change should be reported.

Labeling: The format and content of combination product labeling depends in part on combination product type and how applications are structured. The structure and content of initial product labeling has long-term implications. Chimera assists clients in establishing the optimal format for combination product labeling and can assist in drafting or reviewing client generated labeling and promotional content. Labeling issues can be particularly complex, especially when a combination product is “cross-labeled”.