Conducting Remote Regulatory Assessments Questions and Answers: Draft Guidance for Industry From Food and Drug Administration (FDA) πΊπΈ Draft guidance document providing questions and answers on conducting remote regulatory assessments for various topics including adverse event reporting, compliance, and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
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
Medical devices From European Medicines Agency (EMA) πͺπΊ Medical devices are regulated at EU Member State level, but the European Medicines Agency (EMA) is involved in the regulatory process. Metadata quality: Metadata quality: Data description filled Files documented 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: 66.66666666666666/100 Updated on May 21, 2024 Other (Public Domain) 0 reuses 0 favorites
Q&A on practical aspects related to the implementation of the extended transitional period provided for in the IVDR, as amended by Regulation (EU) 2024/1860 From European Commission πͺπΊ Document covers Q&A on practical aspects of implementing extended transitional period in the IVDR, as amended by Regulation (EU) 2024/1860. 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 July 9, 2024 Creative Commons Attribution 4.0 0 reuses 0 favorites
Q&A on practical aspects related to the implementation of Regulation (EU) 2023/607 - Extension of the MDR transitional period and removal of the βsell offβ periods From European Commission πͺπΊ Q&A on implementing EU Regulation 2023/607, covering MDR transitional period extension and removal of "sell off" periods. 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 July 10, 2024 Creative Commons Attribution 4.0 0 reuses 0 favorites
International scientific guideline: Questions and Answers: Positions on specific questions addressed to the pharmacokinetics working party From Therapeutic Goods Administration (TGA) π¦πΊ EMA/618604/2008 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
Advertising health services and cosmetic injections: frequently asked questions and answers From Therapeutic Goods Administration (TGA) π¦πΊ Find out answers to frequently asked questions about advertising cosmetic injection services and our guidelines. 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 May 22, 2024 Other (Non-Commercial) 0 reuses 0 favorites
Q&As on combination rapid antigen self-tests From Therapeutic Goods Administration (TGA) π¦πΊ We have developed several questions and answers to provide consumers, manufacturers and sponsors information about the supply and use of these tests. 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 May 22, 2024 Other (Non-Commercial) 0 reuses 0 favorites
Medical devices: new guidance for industry and notified bodies From European Medicines Agency (EMA) πͺπΊ A document providing updated guidance for the medical device industry and notified bodies. Metadata quality: Metadata quality: Data description empty Files documented 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 May 21, 2024 Other (Public Domain) 0 reuses 0 favorites
GeGant From European Medicines Agency (EMA) πͺπΊ Information about marketing authorisation application of GeGant, a device to obtain a solution containing radioactive gallium. Metadata quality: Metadata quality: Data description filled Files documented 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: 66.66666666666666/100 Updated on April 26, 2024 Other (Public Domain) 0 reuses 0 favorites
Pathology Peer Review in Nonclinical Toxicology Studies: Questions and Answers From Food and Drug Administration (FDA) πΊπΈ A guidance document titled "Pathology Peer Review in Nonclinical Toxicology Studies: 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 filled Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 66.66666666666666/100 Updated on April 12, 2024 Other (Public Domain) 0 reuses 0 favorites
Use of Whole Slide Imaging in Nonclinical Toxicology Studies: Questions and Answers: Guidance for Industry From Food and Drug Administration (FDA) πΊπΈ A guidance document titled "Use of Whole Slide Imaging in Nonclinical Toxicology Studies: Questions and Answers: Guidance for Industry". 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
Frequently asked questions for the Medical Device Single Audit Program (MDSAP) From Therapeutic Goods Administration (TGA) π¦πΊ Read our questions and answers for sponsors and manufacturers about the Medical Device Single Audit Program (MDSAP). 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 1, 2023 Other (Non-Commercial) 0 reuses 0 favorites
Regulation (EU) 2017/745 β Questions & Answers regarding clinical investigation From European Commission πͺπΊ Regulation (EU) 2017/745 - Q&A on clinical investigation. Covers topics like clinical investigation and evaluation. 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 December 12, 2023 Creative Commons Attribution 4.0 0 reuses 0 favorites
Questions and Answers on Articles 13 & 14 of Regulation (EU) 2017/745 and Regulation (EU) 2017/746 From European Commission πͺπΊ Get answers to questions about Articles 13 & 14 of Regulation (EU) 2017/745 and Regulation (EU) 2017/746 regarding authorised representatives, importers, and distributors. 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 December 20, 2023 Creative Commons Attribution 4.0 0 reuses 0 favorites
Guideline on Questions and Answers Licensing of Medical Device Establishments From South African Health Products Regulatory Authority (SAHPRA) πΏπ¦ Document Number SAHPGL-MD-07 - Version 3 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 November 17, 2023 Other (Public Domain) 0 reuses 0 favorites
Application of Human Factors Engineering Principles for Combination Products: Questions and Answers: Guidance for Industry and FDA Staff From Food and Drug Administration (FDA) πΊπΈ This document is a guidance document titled "Application of Human Factors Engineering Principles for Combination Products" and is intended for industry and FDA staff. It focuses on the topic of combination products. 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 7, 2023 Other (Public Domain) 0 reuses 0 favorites
Q&A From European Commission πͺπΊ This document is a Q&A session that focuses on Annex XVI products. 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 September 27, 2023 Creative Commons Attribution 4.0 0 reuses 0 favorites
MDCG 2021-3 - Questions and answers on custom-made devices and considerations for adaptable medical devices and patient matched medical devices From National Institute of Pharmacy and Nutrition (OGYΓI) ππΊ A document providing guidance on custom-made devices, adaptable medical devices, and patient-matched medical devices, addressing common questions and considerations. 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 2, 2023 Other (Public Domain) 0 reuses 0 favorites
Center for Devices and Radiological Health (CDRH) Appeals Processes: Questions and Answers About 517A: Guidance for Industry and Food and Drug Administration Staff From Food and Drug Administration (FDA) πΊπΈ This document is a guidance document titled "Center for Devices and Radiological Health (CDRH) Appeals Processes" that provides information about 517A and is relevant to administrative/procedural and premarket topics. 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 May 10, 2023 Other (Public Domain) 0 reuses 0 favorites