Complete the sentences with the words from the box

regulatory approval · breakthrough designation · black box warning · surrogate endpoint · pharmacovigilance · post-marketing surveillance · marketing authorization · advisory committee · biosimilar · label indication · regulatory agency · accelerated approval

• Securing full ____ from the FDA requires extensive clinical trial data.
• The pharmaceutical company applied for European ____ last month.
• The British ____ requested additional safety updates on the biologic.
• The drug was granted ____ to expedite access for severe oncology patients in Chicago.
• FDA ____ helped fast-track the novel Alzheimer's treatment.
• An independent ____ will meet in Baltimore to vote on the safety profile.
• Biomarker reduction served as the primary ____ in the pivotal trial.
• Rigorous ____ in New York hospitals tracked rare adverse events.
• The prominent ____ alerted clinicians to severe hepatic risks.
• Expanding the official ____ will allow physicians to treat earlier stages.
• Robust ____ systems across the United States monitor long-term safety.
• The new ____ offers a cost-effective alternative in Boston clinics.

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