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FDA Releases Latest Product-Specific Guidances

Of 36 PSGs, 22 Are New And 14 Newly-Revised

 
• By Dave Wallace

The latest tranche of product-specific guidances for generic development has been published by the US FDA.

Number 36 House Sign
The FDA has published 36 new or newly-revised product-specific guidances • Source: Shutterstock

The US Food and Drug Administration has published its latest batch of product-specific guidances for generic drug development, with the 36 newly-released documents comprising 22 new guidances and 14 newly-revised PSGs.

“To further facilitate generic drug product availability and to assist the generic pharmaceutical industry with identifying the most appropriate methodology...

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