Public Inspection: Revocation of Regulations: Mutual Recognition of Pharmaceutical Good Manufacturing Practice Reports, Medical Device Quality System Audit Reports, and Certain Medical Device Product Evaluation Reports: United States and The European Community From Food and Drug Administration (FDA) πΊπΈ Document number 2024-21559. Scheduled to be published on 2024-09-20. Metadata quality: Metadata quality: Data description empty Files documentation missing License filled Update frequency followed File formats are open Temporal coverage not set Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 66.66666666666666/100 Updated today Other (Public Domain) 0 reuses 0 favorites
Medical device reforms: consumer representation on expert working groups From Therapeutic Goods Administration (TGA) π¦πΊ The TGA works with subject matter experts in clinical practice and academics in the field on particular devices of concern. Metadata quality: Metadata quality: Data description filled Files documentation missing License filled Update frequency not followed File formats are open Temporal coverage not set Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 66.66666666666666/100 Updated 1 month ago Other (Non-Commercial) 0 reuses 0 favorites
Translation of Good Laboratory Practice Study Reports: Questions and Answers From Food and Drug Administration (FDA) πΊπΈ A guidance document titled "Translation of Good Laboratory Practice Study Reports: Questions and Answers". Metadata quality: Metadata quality: Data description filled Files documentation missing License filled Update frequency not followed File formats are closed Temporal coverage not set Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 55.55555555555556/100 Updated on August 9, 2024 Other (Public Domain) 0 reuses 0 favorites
Process for Handling Referrals to FDA Under 21 CFR 50.54 - Additional Safeguards for Children in Clinical Investigations: Guidance for Clinical Investigators, Institutional Review Boards and Sponsors From Food and Drug Administration (FDA) πΊπΈ This document is a guidance document titled "Process for Handling Referrals to FDA Under 21 CFR 50.54" that provides additional safeguards for children in clinical investigations. It focuses on Good Clinical Practice (GCP). Metadata quality: Metadata quality: Data description filled Files documentation missing License filled Update frequency not followed File formats are closed Temporal coverage filled Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 66.66666666666666/100 Updated on August 9, 2024 Other (Public Domain) 0 reuses 0 favorites
Transparency for machine learning-enabled medical devices: Guiding principles From Health Canada π¨π¦ Guiding principles for good medical device machine learning practice developed by Health Canada, the US Food and Drug Administration and the United Kingdomβs Medicines and Healthcare products Regulatory Agency. Metadata quality: Metadata quality: Data description filled Files documentation missing License filled Update frequency not followed File formats are open Temporal coverage not set Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 66.66666666666666/100 Updated on July 29, 2024 Open Government License 2.0 (Canada) 0 reuses 0 favorites
Good clinical practice for clinical trials From Medicines and Healthcare products Regulatory Agency (MHRA) π¬π§ How to show MHRA you're meeting good clinical practice (GCP) standards and what to expect from an inspection. Metadata quality: Metadata quality: Data description filled Files documentation missing License filled Update frequency not followed File formats are open Temporal coverage not set Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 66.66666666666666/100 Updated on July 22, 2024 Open Government Licence 2.0 (United Kingdom) 0 reuses 0 favorites
Report a perceived breach or questionable practices From Therapeutic Goods Administration (TGA) π¦πΊ Use this form to report a perceived breach of the Therapeutic Goods Act, counterfeit products or questionable practices in relation to therapeutic products. Metadata quality: Metadata quality: Data description filled Files documentation missing License filled Update frequency not followed File formats are open Temporal coverage not set Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 66.66666666666666/100 Updated on July 12, 2024 Other (Non-Commercial) 0 reuses 0 favorites
ICH Guideline for Good Clinical Practice From Therapeutic Goods Administration (TGA) π¦πΊ This guideline is an internationally accepted standard for the designing, conducting, recording and reporting of clinical trials Metadata quality: Metadata quality: Data description filled Files documentation missing License filled Update frequency not followed File formats are open Temporal coverage not set Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 66.66666666666666/100 Updated on June 25, 2024 Other (Non-Commercial) 0 reuses 0 favorites
Court action From Therapeutic Goods Administration (TGA) π¦πΊ It is TGA practice to publish details of regulatory compliance decisions and actions on its website Metadata quality: Metadata quality: Data description empty Files documentation missing License filled Update frequency not followed File formats are open Temporal coverage not set Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 55.55555555555556/100 Updated on June 20, 2024 Other (Non-Commercial) 0 reuses 0 favorites
Good Clinical Practice (GCP) Inspection Program From Therapeutic Goods Administration (TGA) π¦πΊ Clinical trials of medicines and biologicals regulated under the CTN or CTA schemes are subject to the TGA's Good Clinical Practice (GCP) Inspection Program. Metadata quality: Metadata quality: Data description filled Files documentation missing License filled Update frequency not followed File formats are open Temporal coverage not set Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 66.66666666666666/100 Updated on June 5, 2024 Other (Non-Commercial) 0 reuses 0 favorites
Processes and Practices Applicable to Bioresearch Monitoring Inspections: Draft Guidance for Industry From Food and Drug Administration (FDA) πΊπΈ A draft guidance document for the biopharmaceutical industry covering processes and practices for bioresearch monitoring inspections, including topics like compliance, inspections, and various drug categories. Metadata quality: Metadata quality: Data description filled Files documentation missing License filled Update frequency not followed File formats are closed Temporal coverage not set Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 55.55555555555556/100 Updated on June 4, 2024 Other (Public Domain) 0 reuses 0 favorites
21 CFR Chapter I Subchapter H β Medical Devices β Part 800 General From Food and Drug Administration (FDA) πΊπΈ 21 CFR Chapter I Subchapter H - Medical Devices - Part 800 General: A regulation governing medical devices. Metadata quality: Metadata quality: Data description filled Files documented License filled Update frequency not followed File formats are open Temporal coverage not set Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 77.77777777777779/100 Updated on June 4, 2024 Other (Public Domain) 0 reuses 0 favorites
Informed Consent: Guidance for IRBs, Clinical Investigators, and Sponsors From Food and Drug Administration (FDA) πΊπΈ A guidance document providing information on informed consent for IRBs, clinical investigators, and sponsors, focusing on Good Clinical Practice (GCP). Metadata quality: Metadata quality: Data description filled Files documentation missing License filled Update frequency not followed File formats are closed Temporal coverage not set Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 55.55555555555556/100 Updated on April 11, 2024 Other (Public Domain) 0 reuses 0 favorites
Minutes of Institutional Review Board (IRB) Meetings: Guidance for Institutions and IRBs From Food and Drug Administration (FDA) πΊπΈ This document provides guidance for institutions and IRBs on conducting and documenting minutes of IRB meetings, focusing on Good Clinical Practice (GCP). Metadata quality: Metadata quality: Data description filled Files documentation missing License filled Update frequency not followed File formats are closed Temporal coverage filled Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 66.66666666666666/100 Updated on April 11, 2024 Other (Public Domain) 0 reuses 0 favorites
Institutional Review Boards Frequently Asked Questions: Guidance for Institutional Review Boards and Clinical Investigators From Food and Drug Administration (FDA) πΊπΈ An information sheet providing guidance for Institutional Review Boards and Clinical Investigators on Good Clinical Practice (GCP) FAQs. Metadata quality: Metadata quality: Data description filled Files documentation missing License filled Update frequency not followed File formats are closed Temporal coverage filled Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 66.66666666666666/100 Updated on April 11, 2024 Other (Public Domain) 0 reuses 0 favorites
Evaluation and Reporting of Age-, Race-, and Ethnicity-Specific Data in Medical Device Clinical Studies: Guidance for Industry and Food and Drug Administration Staff From Food and Drug Administration (FDA) πΊπΈ This document is a guidance document titled "Evaluation and Reporting of Age-, Race-, and Ethnicity-Specific Data in Medical Device Clinical Studies" for the industry and FDA staff. It covers topics such as clinical studies, good clinical practice, labeling, and premarket evaluation. Metadata quality: Metadata quality: Data description filled Files documentation missing License filled Update frequency not followed File formats are closed Temporal coverage filled Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 66.66666666666666/100 Updated on April 8, 2024 Other (Public Domain) 0 reuses 0 favorites
TIWGG meeting summaries From Therapeutic Goods Administration (TGA) π¦πΊ TGA-Industry Working Group on Good Manufacturing Practice (TIWGG) meeting summaries. Metadata quality: Metadata quality: Data description empty Files documentation missing License filled Update frequency not followed File formats are open Temporal coverage not set Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 55.55555555555556/100 Updated on February 22, 2024 Other (Non-Commercial) 0 reuses 0 favorites
Medical Devices; Quality System Regulation Amendments From Food and Drug Administration (FDA) πΊπΈ Document number 2024-01709. The Food and Drug Administration (FDA, the Agency, or we) is issuing a final rule to amend the device current good manufacturing practice (CGMP) requirements of the Quality System (QS) regulation to harmonize and modernize the regulation. We are harmonizing to alignβ¦ Metadata quality: Metadata quality: Data description filled Files documentation missing License filled Update frequency not followed File formats are open Temporal coverage not set Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 66.66666666666666/100 Updated on February 2, 2024 Other (Public Domain) 0 reuses 0 favorites
21 CFR Chapter I Subchapter H β Medical Devices β Part 812 Investigational Device Exemptions From Food and Drug Administration (FDA) πΊπΈ Regulation on Investigational Device Exemptions under 21 CFR Chapter I Subchapter H - Medical Devices - Part 812. Metadata quality: Metadata quality: Data description filled Files documented License filled Update frequency not followed File formats are open Temporal coverage not set Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 77.77777777777779/100 Updated on January 23, 2024 Other (Public Domain) 0 reuses 0 favorites
The role of the TGA From Therapeutic Goods Administration (TGA) π¦πΊ You have probably learned a bit about the TGA through your professional practice, but there are aspects of our work that you may not be aware of. Metadata quality: Metadata quality: Data description filled Files documentation missing License filled Update frequency not followed File formats are open Temporal coverage not set Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 66.66666666666666/100 Updated on December 21, 2023 Other (Non-Commercial) 0 reuses 0 favorites