Incorporating Voluntary Patient Preference Information over the Total Product Life Cycle: Draft Guidance for Industry, Food and Drug Administration Staff, and Other Interested Parties From Food and Drug Administration (FDA) πΊπΈ A draft guidance document by the FDA for industry, staff, and interested parties on incorporating voluntary patient preference information throughout a product's life cycle. 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 week 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Conducting Remote Regulatory Assessments Questions and Answers: Draft Guidance for Industry From Food and Drug Administration (FDA) πΊπΈ Draft guidance document providing questions and answers on conducting remote regulatory assessments for various topics including adverse event reporting, compliance, and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
Predetermined Change Control Plans for Medical Devices: Draft Guidance for Industry and FDA Staff From Food and Drug Administration (FDA) πΊπΈ Draft guidance document for industry and FDA staff on predetermined change control plans for medical devices in the premarket phase. 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
COMMISSION IMPLEMENTING REGULATION (EU) β¦/... amending Implementing Regulation (EU) 2022/1107 laying down common specifications for certain class D in vitro diagnostic medical devices in accordance with Regulation (EU) 2017/746 of the European Parliament and of the Council From European Parliament πͺπΊ A draft implementing regulation amending specifications for class D in vitro diagnostic medical devices under EU Regulation 2017/746. 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 19, 2024 Creative Commons Attribution 4.0 0 reuses 0 favorites
Glass Syringes for Delivering Drug and Biological Products: Technical Information to Supplement International Organization for Standardization (ISO) Standard 11040-4: Draft Guidance for Industry and FDA Staff From Food and Drug Administration (FDA) πΊπΈ This document is a draft guidance for industry and FDA staff on using glass syringes for delivering drug and biological 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 August 9, 2024 Other (Public Domain) 0 reuses 0 favorites
Complementary and Alternative Medicine Products and their Regulation by the Food and Drug Administration: Draft Guidance for Industry From Food and Drug Administration (FDA) πΊπΈ Draft guidance document by the FDA on the regulation of complementary and alternative medicine products, covering administrative 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 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
Updates to the list of recognized standards for medical devices and draft guidance: Notice From Health Canada π¨π¦ Notice on Health Canada's proposed changes to the guidance on recognized standards for medical devices. 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 25, 2024 Open Government License 2.0 (Canada) 0 reuses 0 favorites
Share your views: Updates made to list of recognized standards for medical devices and draft guidance From Health Canada π¨π¦ Health Canada invites you to comment on proposed changes to the guidance on the list of recognized standards for medical devices 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 25, 2024 Open Government License 2.0 (Canada) 0 reuses 0 favorites
Considerations for Long-Term Clinical Neurodevelopmental Safety Studies in Neonatal Product Development: Draft Guidance for Industry From Food and Drug Administration (FDA) πΊπΈ Draft guidance document for industry on conducting long-term clinical neurodevelopmental safety studies in neonatal product development. 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 23, 2024 Other (Public Domain) 0 reuses 0 favorites
Dental Curing Lights - Premarket Notification (510(k)) Submissions: Draft Guidance for Industry and Food and Drug Administration Staff From Food and Drug Administration (FDA) πΊπΈ A guidance document for industry and FDA staff on premarket notification (510(k)) submissions for dental curing lights. 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 11, 2024 Other (Public Domain) 0 reuses 0 favorites
Dental Composite Resin Devices - Premarket Notification (510(k)) Submissions: Draft Guidance for Industry and Food and Drug Administration Staff From Food and Drug Administration (FDA) πΊπΈ A draft guidance document for industry and FDA staff on premarket notification (510(k)) submissions for dental composite resin devices. 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 11, 2024 Other (Public Domain) 0 reuses 0 favorites
Essential Drug Delivery Outputs for Devices Intended to Deliver Drugs and Biological Products: Draft Guidance for Industry From Food and Drug Administration (FDA) πΊπΈ A draft guidance document outlining essential drug delivery requirements for devices intended to administer drugs and biological 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 July 8, 2024 Other (Public Domain) 0 reuses 0 favorites
Diversity Action Plans to Improve Enrollment of Participants from Underrepresented Populations in Clinical Studies: Draft Guidance for Industry From Food and Drug Administration (FDA) πΊπΈ Draft guidance for industry on implementing diversity action plans to enhance enrollment of underrepresented populations in clinical studies. 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 3, 2024 Other (Public Domain) 0 reuses 0 favorites
COMMISSION IMPLEMENTING REGULATION (EU) β¦/... laying down, pursuant to Regulation (EU) 2021/2282 of the European Parliament and of the Council, detailed procedural rules for the cooperation of the Member State Coordination Group on Health Technology Assessment and the Commission with the European Medicines Agency in the form of exchange of information as regards the joint clinical assessment of medicinal products and medical devices and in vitro diagnostic medical devices and as regards the joint scientific consultation on medicinal products and medical devices From European Parliament πͺπΊ A draft implementing regulation detailing procedural rules for cooperation among Member State Coordination Group, Commission, and European Medicines Agency on joint clinical assessments and scientific consultations for medicinal products and medical devices. 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 26, 2024 Creative Commons Attribution 4.0 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
Enforcement Policy for Certain In Vitro Diagnostic Devices for Immediate Public Health Response in the Absence of a Declaration under Section 564: Draft Guidance for Laboratory Manufacturers and Food and Drug Administration Staff From Food and Drug Administration (FDA) πΊπΈ Draft guidance document for laboratory manufacturers and FDA staff on enforcement policy for certain in vitro diagnostic devices during public health emergencies without a Section 564 declaration. Focuses on outbreak response. 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 29, 2024 Other (Public Domain) 0 reuses 0 favorites
Consideration of Enforcement Policies for Tests During a Section 564 Declared Emergency: Draft Guidance for Industry and Food and Drug Administration Staff From Food and Drug Administration (FDA) πΊπΈ Draft guidance document discussing enforcement policies for tests during a Section 564 declared emergency, aimed at industry and FDA staff. Focuses on outbreak-related topics. 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 29, 2024 Other (Public Domain) 0 reuses 0 favorites
Draft Australian UDI Bulk Upload Template From Therapeutic Goods Administration (TGA) π¦πΊ A Microsoft Excel template for sponsors and manufacturers for uploading bulk UDI records to the Australian UDI Database 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 April 16, 2024 Other (Non-Commercial) 0 reuses 0 favorites
Ethical Considerations for Clinical Investigations of Medical Products Involving Children: Draft Guidance for Industry, Sponsors, and IRBs From Food and Drug Administration (FDA) πΊπΈ This document is a draft guidance for industry, sponsors, and IRBs on ethical considerations for clinical investigations involving children. 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