Guidance for Industry: Color Additive Petitions - FDA Recommendations for Submission of Chemical and Technological Data on Color Additives for Food, Drugs, Cosmetics, or Medical Devices From Food and Drug Administration (FDA) πΊπΈ This document provides FDA recommendations for submitting chemical and technological data on color additives for food, drugs, cosmetics, or medical devices. 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 1 week ago Other (Public Domain) 0 reuses 0 favorites
Recommendations for Clinical Laboratory Improvement Amendments of 1988 (CLIA) Waiver Applications for Manufacturers of In Vitro Diagnostic Devices: Guidance for Industry and Food and Drug Administration Staff From Food and Drug Administration (FDA) πΊπΈ This document provides guidance for manufacturers of in vitro diagnostic devices on Clinical Laboratory Improvement Amendments (CLIA) waiver applications. 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
Recommendations for MDs From National Agency for the Safety of Medicines and Health Products (ANSM) π«π· Reference document Recommendations for MDs in your application process 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 30, 2024 Other (Non-Commercial) 0 reuses 0 favorites
Recommendations for MD/IVDMD advertising From National Agency for the Safety of Medicines and Health Products (ANSM) π«π· Reference document Recommendations for advertising MD/IVDMD in your application process 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 26, 2024 Other (Non-Commercial) 0 reuses 0 favorites
International scientific guideline: ICH guideline Q4B Annex 4B on evaluation and recommendation of pharmacopoeial texts for use in the ICH regions on tests for specified micro-organisms From Therapeutic Goods Administration (TGA) π¦πΊ EMA/CHMP/ICH/308817/2008 adopted by the Therapeutic Goods Administration (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 June 21, 2024 Other (Non-Commercial) 0 reuses 0 favorites
Information about Poly Implant PIP breast implants From Spanish Agency for Medicines and Medical Devices (AEMPS) πͺπΈ Last update: January 22, 2021 Briefing Notes Protocol for the explantation, follow-up and replacement of Poly Implant Prothese (P.I.P.) breast prostheses List of Reference Centers/Services Briefing Notes October 30, 2013: Update of information and recommendations on Poly Implant ProthΓ¨se (PIP)β¦ 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 10, 2024 Other (Public Domain) 0 reuses 0 favorites
Guidance for Surgical Sutures (MDS-G021) From Saudi Food and Drug Authority (SFDA) πΈπ¦ Document titled "Guidance for Surgical Sutures (MDS-G021)" providing instructions and recommendations related to surgical sutures. 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 March 4, 2024 Other (Public Domain) 0 reuses 0 favorites
Recommendations for IVDMDs From National Agency for the Safety of Medicines and Health Products (ANSM) π«π· Reference document Recommendations for IVDMDs in your application process 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 December 29, 2023 Other (Non-Commercial) 0 reuses 0 favorites
Medical Devices with Indications Associated with Weight Loss - Non-Clinical Recommendations: Draft Guidance for Industry and Food and Drug Administration Staff From Food and Drug Administration (FDA) πΊπΈ Draft guidance document for industry and FDA staff on non-clinical recommendations for medical devices associated with weight loss indications. 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 September 14, 2023 Other (Public Domain) 0 reuses 0 favorites
Recommendations for the Use of Clinical Data in Premarket Notification [510(k)] Submissions: Draft Guidance for Industry and Food and Drug Administration Staff From Food and Drug Administration (FDA) πΊπΈ Draft guidance document for industry and FDA staff on using clinical data in premarket notification submissions. 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 September 6, 2023 Other (Public Domain) 0 reuses 0 favorites
Hydrogen Peroxide-Based Contact Lens Care Products: Consumer Labeling Recommendations - Premarket Notification (510(k)) Submissions: Guidance for Industry and Food and Drug Administration Staff From Food and Drug Administration (FDA) πΊπΈ This document provides guidance on labeling recommendations for hydrogen peroxide-based contact lens care products. 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 July 26, 2023 Other (Public Domain) 0 reuses 0 favorites
Final Report on the Australian Government Response to the Recommendations of the Senate Community Affairs References Committee Report From Therapeutic Goods Administration (TGA) π¦πΊ The Australian Government remains committed to the safety, health and wellbeing of all Australians. 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, 2023 Other (Non-Commercial) 0 reuses 0 favorites
Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence/Machine Learning (AI/ML)-Enabled Device Software Functions: Draft Guidance for Industry and Food and Drug Administration Staff From Food and Drug Administration (FDA) πΊπΈ This document is a draft guidance for the FDA and industry staff on marketing submission recommendations for AI/ML-enabled device software functions. 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 March 30, 2023 Other (Public Domain) 0 reuses 0 favorites
Laser-Assisted In Situ Keratomileusis (LASIK) Lasers - Patient Labeling Recommendations: Draft Guidance for Industry and Food and Drug Administration Staff From Food and Drug Administration (FDA) πΊπΈ This document is a draft guidance for industry and FDA staff on labeling recommendations for LASIK lasers used in patient treatment. 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 October 7, 2022 Other (Public Domain) 0 reuses 0 favorites
Recommendation for a COUNCIL DECISION authorising the opening of negotiations on behalf of the European Union for a Council of Europe convention on artificial intelligence, human rights, democracy and the rule of law From European Parliament πͺπΊ This document is a recommendation for the European Union to open negotiations on a Council of Europe convention on artificial intelligence and human rights. 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 August 18, 2022 Creative Commons Attribution 4.0 0 reuses 0 favorites
Australian Government response to the Review of the Reforms to the Therapeutic Goods Advertising Framework From Therapeutic Goods Administration (TGA) π¦πΊ The Australian Government has accepted all 22 recommendations 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 30, 2022 Other (Non-Commercial) 0 reuses 0 favorites
TGC meeting 35, 14 October 2009 From Therapeutic Goods Administration (TGA) π¦πΊ Meeting report and recommendations from TGC meeting 35 on October 14, 2009. 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, 2022 Other (Non-Commercial) 0 reuses 0 favorites
TGC meeting 34, 13 May 2009 From Therapeutic Goods Administration (TGA) π¦πΊ Meeting report and recommendations from TGC meeting 34 on 13 May 2009. 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, 2022 Other (Non-Commercial) 0 reuses 0 favorites
TGC meeting 33, 15-16 October 2008 From Therapeutic Goods Administration (TGA) π¦πΊ Meeting report and recommendations from TGC meeting 33 held on 15-16 October 2008. 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, 2022 Other (Non-Commercial) 0 reuses 0 favorites
TGC meeting 32, 29 April 2008 From Therapeutic Goods Administration (TGA) π¦πΊ Meeting report and recommendations from TGC meeting 32 on 29 April 2008. 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, 2022 Other (Non-Commercial) 0 reuses 0 favorites