Regulatory Considerations for Human Cells, Tissues, and Cellular and Tissue-Based Products: Minimal Manipulation and Homologous Use
On 21 July 2020 the FDA announced the availability of the final guidance for industry and FDA staff.
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EMA Updated EudraVigilance Registration Manual
On 21 July 2020 the EMA announced the availability of the updated EudraVigilance registration manual.
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EMA Updated the GCP Q&A
On 24 July 2020 the EMA updated the GCP Q&A.
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MHRA Planning for Return to On-site Good Practice (GxP) Inspections
On 23 July 2020 it was published on the MHRA Inspectorate Blog that MHRA is planning for return to on-site GxP inspections.
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Expiration Dating of Unit-Dose Repackaged Solid Oral Dosage Form Drug Products
On 29 July 2020 the FDA issued the final guidance for industry.
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