Examples of using Draft guidance in English and their translations into German
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Medicine
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Colloquial
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Official
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Ecclesiastic
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Financial
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Ecclesiastic
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Political
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Computer
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Programming
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Official/political
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Political
Final and draft guidance documents.
ASRs: comment period extended on draft guidance.
UK MHRA issues draft guidance on vigilance systems.
Bayesian statistics in clinical trials: draft guidance.
Canadian draft guidance on hospital bed safety.
Latex free' labelling to be replaced under new draft guidance.
Consultation of draft guidance on new annex to CLP.
USA: Common questions on the HDE programme addressed in new draft guidance.
Health Canada issues draft guidance on supporting evidence.
Staff recommendation That the Board approve the draft guidance.
FDA issues draft guidance on mobile medical applications.
USA: Recognition and withdrawal of voluntary consensus standards addressed in draft guidance.
EMA/Commission draft guidance on ATMPs containing a device.
USA: Eliminating routine FDA re-review of third party 510(k) reviews:formal plan and draft guidance.
Health Canada issues draft guidance on content of QMS audit reports.
Draft guidance for identifying endocrine disruptors has been developed and is currently subject to expert consultation.
The seminar enabled the draft guidance paper to take final form.
USA: Draft guidance on content of pre-market submissions for management of cybersecurity in medical devices.
Use of public human genetic variant databases tosupport clinical validity for NGS-based IVDs: draft guidance issued.
Canada: Draft guidance on licensing requirements for 3D printed medical devices.
The European Food Safety Authority(EFSA) has opened a public consultation on its draft guidance for the risk assessment of nanoscience and nanotechnology applications in the food and feed chain.
USA: Draft guidance on IVDs used in clinical investigations of therapeutic products circulated for public comment.
Because information on the efficacy and safety of ticagrelor- particularly the riskof bleeding- beyond three years is limited, the draft guidance does not recommend treatment with it beyond that period.
Singapore publishes draft guidance on grouping of medical devices for product registration.
The U.S. Food and Drug Administration(FDA) issued three documents on the safety of animal cloning-- a draft risk assessment; aproposed risk management plan; and a draft guidance for industry.
A draft guidance on harmonised information relating to emergency health response under Annex VIII to CLP has been published.
Health Canada drafts guidance on‘significant change.
France drafts guidance on medical device maintenance.
In addition EMEA has drafted guidance and begun work on a project to implement the clinical trial database and the clinical trial part of the EudraVigilance database, for which it is rapporteur.