GMP News

Janet Woodcock new FDA Acting Commissioner

When the new US President Biden took office, the previous FDA Commissioner resigned from his position. Now, Dr Janet Woodcock was named Acting FDA Commissioner.

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Revision of USP <661.1> Plastic Materials

The USP Packaging and Distribution Expert Committee intends to revise USP chapter <661.1> Plastic Materials of Construction. The targeted official date is 1 March 2021.

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Questions and Answers Document on Audit Alternatives of Notified Bodies

In a previous News you could read about audit alternatives of Notified Bodies in Covid-19 times. The guideline was based on a document of the Medical Device Coordination Group (MDCG). This guideline has now been supplemented by a question and answer document.

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Combination Products in the USA

Combination products in the US are separately regulated by the FDA via GMP regulations. A dedicated FDA website provides guidance on combination products. 

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Survey Results on "Remote Audits" of Notified Bodies

Within the framework of a survey via the EU Commission, Notified Bodies in the medical devices sector were asked about their experiences with "remote audits". The results are now available.

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