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GMP News

In-use Storage Time of Reconstituted Medicines

The Council of Europe’s CD-P-PH/PC Committee (co-ordinated by the EDQM) has published a position paper on in-use storage times for reconstituted parenteral medicines. The new paper highlights a gap between the stability data submitted for marketing authorisations and clinical use, calling for regulatory requirements that better reflect hospital practices.

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FDA issues Guidance on Collection of Pregnancy Safety Data

The U.S. Food and Drug Administration issued a guidance on postapproval pregnancy safety studies, with recommendations on different methodologies that can be used to study the safety of drugs and biological products when used during pregnancy.

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Pilot on Real-Time Clinical Trials

The U.S. Food and Drug Administration (FDA) announced major steps as part of an initiative to advance the implementation of real-time clinical trials (RTCTs). In particular, the agency released a Request for Information (RFI) regarding a proposed pilot program that will launch this summer. 

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