FDA guidelines aim to improve quality and lower costs

The US FDA has issued draft guidance intended to promote innovation in pharmaceutical development and manufacturing.

Entitled ‘Program for the Recognition of Voluntary Consensus Standards Related to Pharmaceutical Quality Guidance for Industry,’ the draft guidance has been produced by the US Food and Drug Administration (FDA) to informally recognize voluntary consensus standards relating to pharmaceutical quality for products under the jurisdiction of the Center for Drug Evaluation and Research (CDER).

“The overall goal of this program is to promote development and appropriate use of consensus standards to help expedite pharmaceutical development and streamline the review of drug product applications,” FDA commissioner Scott Gottlieb said in a statement.

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“By providing a list of recognized standards on our website, we will provide transparency regarding our thinking on a particular standard, which will help industry compile information for applications, can streamline the FDA’s assessment and allow us to focus our efforts on developing guidance on other quality topics.”

Once established, the program will facilitate submissions by external stakeholders and CDER staff proposing voluntary consensus standards related to pharmaceutical quality for informal recognition.

The guidance forms part of the Agency’s broader agenda to support efficiency of drug development and manufacturing through greater transparency, and comes following the publication of draft guidance last year, entitled ‘Q12 Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management.’

The full draft can be found below:

CDER’s Program for the Reco… by on Scribd


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