Magazine Article | November 1, 2023

An Overview Of The 9 FDA Special Designations For Pipeline Drugs

Source: Life Science Leader

By Ryan Chandanais

The FDA employs various special designations to streamline and incentivize the advancement of drugs addressing medical gaps. While some designations can accelerate FDA timelines for NDAs and biologics license applications (BLAs), others may abbreviate the duration of clinical trials. This approach grants manufacturers an extended timeframe between drug launches and the eventual loss of exclusivity.

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