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§ 54 Anzeige von Änderungen
(1) Der Sponsor hat Änderungen in den nach § 48 Absatz 2 und § 53 Absatz 2 eingereichten Unterlagen der zuständigen Bunde… +
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§ 54.1 Purpose.
(a) The Food and Drug Administration (FDA) evaluates clinical studies submitted in marketing applications, required by law, for new hu… +
§ 54.1 Purpose.
(a) The Food and Drug Administration (FDA) evaluates clinical studies submitted in marketing applications, required by law, for new hu… +
§ 54.4 Certification and disclosure requirements.
[…]
Clinical investigators subject to investigational new drug or investigational device exemption r… +
§ 54.4 Certification and disclosure requirements.
For purposes of this part, an applicant must submit a list of all clinical investigators who conduct… +
§ 54.6 Recordkeeping and record retention.
(a) Financial records of clinical investigators to be retained. An applicant who has submitted a marketing … +
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§ 55 Antrag bei der Ethik-Kommission bei wesentlichen Änderungen
(1) Beabsichtigt der Sponsor eine Änderung, die wahrscheinlich wesentliche Auswirkun… +
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§ 56.102 Definitions.
[...]
(m) IRB approval means the determination of the IRB that the clinical investigation has been reviewed and may be conducted… +
§ 56.103 Circumstances in which IRB review is required.
(a) Except as provided in §§ 56.104 and 56.105, any clinical investigation which must meet the… +
§ 56.104 Exemptions from IRB requirement.
The following categories of clinical investigations are exempt from the requirements of this part for IRB re… +
§ 56.104 Exemptions from IRB requirement.
The following categories of clinical investigations are exempt from the requirements of this part for IRB re… +
§ 56.105 Waiver of IRB requirement.
On the application of a sponsor or sponsor-investigator, the Food and Drug Administration may waive any of the req… +
§ 56.110 Expedited review procedures for certain kinds of research involving no more than minimal risk, and for minor changes in approved research.
(a… +
§ 56.110 Expedited review procedures for certain kinds of research involving no more than minimal risk, and for minor changes in approved research.
[…… +
§ 56.111 Criteria for IRB approval of research.
[…]
§ 56.112 Review by institution.
Research covered by these regulations that has been approved by an… +
§ 56.113 Suspension or termination of IRB approval of research.
An IRB shall have authority to suspend or terminate approval of research that is not b… +
§ 56.113 Suspension or termination of IRB approval of research.
An IRB shall have authority to suspend or terminate approval of research that is not b… +
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§ 59 Vornahme von wesentlichen Änderungen
Der Sponsor darf die beantragte wesentliche Änderung frühestens 38 Tage nach Erhalt der Mitteilung der zust… +
§ 6 Klassifizierung von Produkten, Feststellung des rechtlichen Status, Einstufung von Produkten der Klasse I, Genehmigungspflicht einer klinischen Pr… +
§ 6 Prüfung der nach Artikel 6 der Verordnung (EU) Nr. 536/2014 in Teil I des Bewertungsberichts zu behandelnden Aspekte
(1) Ist die Bundesrepublik D… +
