Human Resources; Biotechnology & Life Sciences; Regulatory Affairs · medium ·
The expertise wedge forming under the drug-device CRL scrutiny
The demand for experienced clinical and regulatory leaders skilled in navigating complex FDA Complete Response Letters (CRLs) for drug-device combination products is increasing. This is due to pharmaceutical companies expanding R&D into new modalities like a major operator and targeted delivery, alongside more prescriptive another operator requirements from a leading provider, creating a critical shortage of talent that can proactively address regulatory hurdles in high-risk development programs.