CPG Sec 390.100 Definition of βCommerceβ - 21 CFR 1000.3(d) 2 From Food and Drug Administration (FDA) πΊπΈ A Compliance Policy Guide outlining the definition of "Commerce" as per 21 CFR 1000.3(d) 2. Metadata quality: Metadata quality: Data description empty 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: 44.44444444444444/100 Updated 2 weeks ago Other (Public Domain) 0 reuses 0 favorites
Compliance Policy Guides Index From Food and Drug Administration (FDA) πΊπΈ A document outlining an index of Compliance Policy Guides (CPG) for regulatory compliance purposes. Metadata quality: Metadata quality: Data description empty 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: 44.44444444444444/100 Updated 2 weeks ago Other (Public Domain) 0 reuses 0 favorites
Compliance Policy Guide Sec. 390.200 Determination by Secretary that Product Fails to Comply or has Defect - 21 CFR 1003.11 From Food and Drug Administration (FDA) πΊπΈ A document outlining the process for the Secretary to determine non-compliance or defects in products, referencing 21 CFR 1003.11. Part of Compliance Policy Guide (CPG). 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 2 weeks ago Other (Public Domain) 0 reuses 0 favorites
CPG Sec. 160.100 Regulatory Actions and Small Business From Food and Drug Administration (FDA) πΊπΈ CPG Sec. 160.100 provides guidance on regulatory actions and their impact on small businesses. Metadata quality: Metadata quality: Data description empty 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: 55.55555555555556/100 Updated 2 weeks ago Other (Public Domain) 0 reuses 0 favorites
CPG Sec. 110.100 Certification for Exports (Withdrawn 11/04/2021) From Food and Drug Administration (FDA) πΊπΈ This document is a Compliance Policy Guide (CPG) titled "CPG Sec. 110.100 Certification for Exports (Withdrawn 11/04/2021)". 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 2 weeks ago Other (Public Domain) 0 reuses 0 favorites
Conducting Remote Regulatory Assessments Questions and Answers: Draft Guidance for Industry From Food and Drug Administration (FDA) πΊπΈ Draft guidance document providing questions and answers on conducting remote regulatory assessments for various topics including adverse event reporting, compliance, and pharmaceutical quality. 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 2 weeks ago Other (Public Domain) 0 reuses 0 favorites
Mammography Quality Standards Act and Regulation Amendments: Small Entity Compliance Guide: Guidance for Industry and Food and Drug Administration Staff From Food and Drug Administration (FDA) πΊπΈ A guidance document for small entities on complying with amendments to the Mammography Quality Standards Act and Regulations, aimed at industry and FDA staff. 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 1 month ago Other (Public Domain) 0 reuses 0 favorites
Essential Principles checklist From Therapeutic Goods Administration (TGA) π¦πΊ A checklist to help medical device manufacturers prove compliance with the Essential Principles 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 1 month ago Other (Non-Commercial) 0 reuses 0 favorites
Medical Devices Compliance Program Bulletin From Health Canada π¨π¦ Information on regulatory activities, process changes and hot issues regarding medical device establishment licencing. 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 26, 2024 Open Government License 2.0 (Canada) 0 reuses 0 favorites
News and information From Therapeutic Goods Administration (TGA) π¦πΊ Find the latest news stories and information on TGA compliance activity. 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 July 12, 2024 Other (Non-Commercial) 0 reuses 0 favorites
Compliance undertaking From Therapeutic Goods Administration (TGA) π¦πΊ A written undertaking is an alternative to court action being commenced by the TGA. 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 July 1, 2024 Other (Non-Commercial) 0 reuses 0 favorites
Laboratory Developed Tests: Small Entity Compliance Guide: Guidance for Laboratory Manufacturers and Food and Drug Administration Staff From Food and Drug Administration (FDA) πΊπΈ A guidance document for laboratory manufacturers and FDA staff on compliance with regulations for Laboratory Developed Tests (LDTs). 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 24, 2024 Other (Public Domain) 0 reuses 0 favorites
Legal framework From Therapeutic Goods Administration (TGA) π¦πΊ Information on advertising legislation and how we manage advertising compliance. 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 21, 2024 Other (Non-Commercial) 0 reuses 0 favorites
Demonstrating compliance with the Essential Principles From Therapeutic Goods Administration (TGA) π¦πΊ Manufacturers are responsible for generating, collating, assessing, and maintaining scientific and engineering evidence that shows that their devices comply with the Essential Principles (the Principles). 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 21, 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
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 898 Performance Standard for Electrode Lead Wires and Patient Cables From Food and Drug Administration (FDA) πΊπΈ This document is a regulation titled "Performance Standard for Electrode Lead Wires and Patient Cables" under 21 CFR Chapter I Subchapter H. 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
Guideline on control of impurities of pharmacopoeial substances: compliance with the European Pharmacopoeia general monograph "Substances for pharmaceutical use" and general chapter "Control of impurities in substances for pharmaceutical use" From Therapeutic Goods Administration (TGA) π¦πΊ We have adopted this International Scientific Guideline - CPMP/QWP/1529/04. 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 3, 2024 Other (Non-Commercial) 0 reuses 0 favorites
Medical devices regulations: compliance and enforcement From Medicines and Healthcare products Regulatory Agency (MHRA) π¬π§ Information on MHRA's enforcement duties and how to report a non-compliant medical device. 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 May 17, 2024 Open Government Licence 2.0 (United Kingdom) 0 reuses 0 favorites
ZL000_00_036e_WL Guidance document GMP compliance by foreign manufacturers From Swiss Agency for Therapeutic Products (Swissmedic) π¨π Guidance document on GMP compliance by foreign manufacturers. Metadata quality: Metadata quality: Data description empty 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: 44.44444444444444/100 Updated on April 15, 2024 Other (Non-Commercial) 0 reuses 0 favorites