Investigating Out-of-Specification (OOS) Test Results for Pharmaceutical Production
On 16 May 2022 the FDA published Final Level 2 revised guidance.
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Safety Considerations for Container Labels and Carton Labeling Design to Minimize Medication Errors
On 18 May 2022 the FDA published the final guidance on safety considerations for labeling.
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Annual Report of the Good Clinical Practice Inspectors’ Working Group 2020
On 20 May 2022 the EMA published the annual report of the GCP IWG, which was adopted by the GCP IWG on 30 April 2022.
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How to Notify the MHRA about a Clinical Investigation for a Medical Device
On 19 May 2022 the UK MHRA updated the guidance on notifying the MHRA of the intention to conduct a clinical investigation for medical devices.
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Risk Management Plans to Mitigate the Potential for Drug Shortages
On 20 May 2022 the FDA published the draft guidance on risk management plans for drug shortages. Comments may be submitted until 19 July 2022.
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