Sentence examples for submission dossier from inspiring English sources

32 According to this policy, EMA will make clinical study reports and parts of the regulatory submission dossier publicly available.

(In the present article, the terms "dossier" and "module" refer exclusively to documents submitted by companies to the Federal Joint Committee within the framework of AMNOG; they do not refer to documents submitted to regulatory authorities as part of the regulatory submission dossier, the common technical document).

Some respondents recognised the need to differentiate training dependant on role, recognising expertise in clinical trials or review of submission dossiers.

Within 3 months of submission, the dossier is evaluated in most cases by the Institute for Quality and Efficiency in Health Care (IQWiG) [ 2].

Therefore a comparison of dossiers with indirect comparisons is challenging as with block scoping reports, policy statements and guidelines the submission of a dossier is not mandatory for manufacturers.

Cardiff have not commented since the submission of the dossier.

Suvorexant has since progressed to Phase III and dossier submission to the FDA.

We anticipate that the final step, submission of the dossier to Parliament, will take place in the next few months.

The Medicines and Healthcare Products Regulatory Authority (MHRA) which licenses drugs is reviewing Dianette following the submission of a dossier from the charity April (Adverse Psychiatric Reactions Information Link).

The first registration phase saw several version changes in the IUCLID software for dossier submission.

When renouncing a dossier submission (n = 5) the negotiated average discount was 31.51 % [3.97 78.02; SD 29.95] vs. 23.84 % [0 67.30; SD 13.0] with dossier submission and the GBA granted "no additional benefit" (n = 86).