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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