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US FDA Considers Making More Guidance Final Without Public Comment

 
• By Derrick Gingery

Increased use of the ‘immediate implementation’ provision in the agency’s Good Guidance Practices could help reduce stakeholder uncertainty.

Male hand draws a curved line that guides a paper boat to cross the barriers. Guidance, assistance, leadership or to overcome obstacles concept.
To use the ‘immediately implementation’ provision, public comment has to be deemed not feasible or inappropriate. • Source: Shutterstock

Sponsors and stakeholders soon could see more new US Food and Drug Administration guidances that skip the public comment process before coming into effect in an effort to speed publication of agency thinking.

Many guidances are issued in draft form at first. After a public comment period, the agency reviews the responses and...

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