Guidance for Notified Bodies, Distributors and Importers on Certification Activities in Accordance with Article 16(4) of Regulation (EU) 2017/745 and Regulation (EU) 2017/746
In August 2021 the Medical Device Coordination Group (MDCG) published guidance of MDCG 2021-23.
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DAIDS Good Clinical Laboratory Practice Guidelines
On 16 August 2021 the Division of AIDS (DAIDS) in the U.S. National Institute of Allergy and Infectious Diseases (NIAID) published the GCLP guidelines.
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Australian Therapeutic Goods Administration (TGA) Reduces Timeframe for Publishing Adverse Event Reports
On 19 August 2021 the TGA announced a reduced timeframe for publishing adverse event reports.
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General Principles EMA-FDA Parallel Scientific Advice (Human Medicinal Products)
On 18 August 2021 the EMA published updated general principles on EMA-FDA parallel scientific advice.
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Notifying FDA of Fatalities Related to Blood Collection or Transfusion
On 20 August 2021 the FDA announced updated guidance for industry.
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