Risklick Provides Clinical Trial Educational Programs
The Clinical Trial Academy Essential Program provided by Risklick is aimed to address the difficulties in developing an ideal clinical trial protocol.
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Use of Circulating Tumor DNA for Early-Stage Solid Tumor Drug Development
On 2 May 2022 the FDA announced the availability of the draft guidance for industry.
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Supplements for Approved Premarket Approval (PMA) or Humanitarian Device Exemption (HDE) Submissions During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency (Revised)
On 4 May 2022 the FDA published the final guidance for industry and FDA staff.
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ICH Guideline Q3D (R2) on Elemental Impurities
On 3 May 2022 the EMA published step 5 of the revised ICH guideline Q3D (R2) on elemental impurities.
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Clinical Pharmacology Considerations for Human Radiolabeled Mass Balance Studies
On 5 May 2022 the FDA published the draft guidance for industry. Comments may be submitted until 4 August 2022.
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