Exhaustive Extractions

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FDA Updates Comment Period for new GLP Regulations

On October 31, 2016 the US FDA published a notification in the Federal Register (81 FR 75351) extending the comment period for the Agency’s proposal to amend the good laboratory practice (GLP) regulations for nonclinical studies. This extension was due to requests from interested parties asking that the original 90-day comment period be extended by an additional 90-days to allow sufficient time for the partied to develop meaningful and thoughtful responses to the proposed rule.

Although the FDA did not grant the full 90-day extension, the Agency did extend the comment period by 60 days, which the Agency described in the notification as adequate time for interested parties to submit comments without causing significant delays to the rulemaking process.

As a result of this extension, the closing date of the comment period has been extended from November 16, 2016 to January 21, 2017.

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Comments 3

 
Guest - Josey I. on Friday, 14 July 2017 06:33

And just to remind that according to FDA these proposals that are meant to amend the regulations for GLP for nonclinical laboratory studies are intended to build quality into planning, conducting, reporting a nonclinical laboratory study and to help ensuring data quality and integrity. And, as the importance of GLP is so obvious, it’s good for these practices to be amended in order to reflect the best current practices for better results.

And just to remind that according to FDA these proposals that are meant to amend the regulations for GLP for nonclinical laboratory studies are intended to build quality into planning, conducting, reporting a nonclinical laboratory study and to help ensuring data quality and integrity. And, as the importance of GLP is so obvious, it’s good for these practices to be amended in order to reflect the best current practices for better results.
Ahmed Khan on Thursday, 26 October 2017 09:21

Nice post...

Nice post...
Guest - Allan on Friday, 17 November 2017 08:01

Thank you for the information! Sure, these new regulations are reflected in a GLP training that provide an overview of the requirements of regulatory authorities, concerning non-clinical studies.

Thank you for the information! Sure, these new regulations are reflected in a GLP training that provide an overview of the requirements of regulatory authorities, concerning non-clinical studies.
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