By publishing more than 200 complete response letters, the FDA is offering new visibility into the issues that most often delay drug approvals, including safety concerns, trial design flaws, and manufacturing gaps.
Outdated regulations and inflexible sponsor processes are hampering clinical trial recruitment, but empowering sites with modern, compliant marketing tools could turn the tide.
As clinical research increasingly relies on RWD to enhance trial design and patient insights, tokenization has emerged as a critical solution for securely linking disparate datasets while protecting patient privacy.
Under the new initiative, companies may receive a voucher enabling FDA review to be shortened from the standard 10–12 months to just 1–2 months following final application submission if the drug addresses US national health priorities.