Submission and Resolution of Formal Disputes Regarding the Timeliness of Premarket Review of a Combination Product: Guidance for Industry and FDA Staff From Food and Drug Administration (FDA) πΊπΈ This is a guidance document titled "Submission and Resolution of Formal Disputes Regarding the Timeliness of Premarket Review of a Combination Product". It focuses on combination 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
Application User Fees for Combination Products: Guidance for Industry and FDA Staff From Food and Drug Administration (FDA) πΊπΈ This document provides guidance on application user fees for combination products for 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 filled Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 66.66666666666666/100 Updated on July 16, 2024 Other (Public Domain) 0 reuses 0 favorites
Purpose and Content of Use-Related Risk Analyses for Drugs, Biological Products, and Combination Products From Food and Drug Administration (FDA) πΊπΈ Guidance document outlining the purpose and content of use-related risk analyses for drugs, biological products, and 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 July 9, 2024 Other (Public Domain) 0 reuses 0 favorites
Boundary and combination products From Therapeutic Goods Administration (TGA) π¦πΊ A guide to help sponsors figure out if their therapeutic goods are medicines, biologicals, or 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 May 3, 2024 Other (Non-Commercial) 0 reuses 0 favorites
Current Good Manufacturing Practice Requirements for Combination Products: Guidance for Industry and FDA Staff From Food and Drug Administration (FDA) πΊπΈ This document provides guidance on current good manufacturing practice requirements for combination products in the pharmaceutical 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 September 29, 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
Certain Ophthalmic Products: Policy Regarding Compliance With 21 CFR Part 4 Guidance for Industry: Guidance for Industry From Food and Drug Administration (FDA) πΊπΈ This document is a guidance for the industry on compliance with 21 CFR Part 4 for certain ophthalmic products, focusing on combination 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 March 22, 2022 Other (Public Domain) 0 reuses 0 favorites
Medical Devices; Quality System Regulation Amendments From Food and Drug Administration (FDA) πΊπΈ Document number 2022-03227. The Food and Drug Administration (FDA, the Agency, or we) is proposing to amend the device current good manufacturing practice (CGMP) requirements of the Quality System (QS) Regulation to align more closely with the international consensus standard for devices byβ¦ 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 23, 2022 Other (Public Domain) 0 reuses 0 favorites
Principles of Premarket Pathways for Combination Products: Guidance for Industry and FDA Staff From Food and Drug Administration (FDA) πΊπΈ This document is a guidance for industry and FDA staff on the principles of premarket pathways for combination 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 January 28, 2022 Other (Public Domain) 0 reuses 0 favorites
Medical Device De Novo Classification Process From Food and Drug Administration (FDA) πΊπΈ Document number 2021-21677. The Food and Drug Administration (FDA) is issuing a final rule to establish requirements for the medical device De Novo classification process under the Federal Food, Drug, and Cosmetic Act (FD&C Act). This final rule establishes procedures and criteria related toβ¦ 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 October 5, 2021 Other (Public Domain) 0 reuses 0 favorites
Submissions for Postapproval Modifications to a Combination Product Approved Under a BLA, NDA, or PMA: Draft Guidance for Industry and FDA Staff From Food and Drug Administration (FDA) πΊπΈ Draft guidance for industry and FDA staff on submissions for postapproval modifications to combination products approved under a BLA, NDA, or PMA. 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 13, 2021 Other (Public Domain) 0 reuses 0 favorites
How to Write a Request for Designation (RFD): Guidance for Industry From Food and Drug Administration (FDA) πΊπΈ Learn how to write a Request for Designation (RFD) with this industry guidance document focused on Combination 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 May 13, 2021 Other (Public Domain) 0 reuses 0 favorites
Early Development Considerations for Innovative Combination Products: Guidance for Industry and FDA Staff From Food and Drug Administration (FDA) πΊπΈ This document provides guidance for the development of innovative combination products, 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 filled Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 66.66666666666666/100 Updated on May 13, 2021 Other (Public Domain) 0 reuses 0 favorites
Classification of Products as Drugs and Devices and Additional Product Classification Issues: Guidance for Industry and FDA Staff From Food and Drug Administration (FDA) πΊπΈ This document provides guidance for classifying products as drugs and devices, with a focus on combination 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 May 13, 2021 Other (Public Domain) 0 reuses 0 favorites
Requesting FDA Feedback on Combination Products : Guidance for Industry and FDA Staff From Food and Drug Administration (FDA) πΊπΈ This document is a guidance for requesting FDA feedback on combination products, focusing on over-the-counter 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 January 20, 2021 Other (Public Domain) 0 reuses 0 favorites
Bridging for Drug-Device and Biologic-Device Combination Products: Draft Guidance for Industry From Food and Drug Administration (FDA) πΊπΈ Draft guidance document for industry on bridging for drug-device and biologic-device combination products. Focuses on combination 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 6, 2020 Other (Public Domain) 0 reuses 0 favorites
New Contrast Imaging Indication Considerations for Devices and Approved Drug and Biological Products: Guidance for Industry From Food and Drug Administration (FDA) πΊπΈ Guidance for Industry on new contrast imaging indication considerations for combination products and approved 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 May 14, 2020 Other (Public Domain) 0 reuses 0 favorites
Compliance Policy for Combination Product Postmarketing Safety Reporting: Immediately in Effect Guidance for Industry and Food and Drug Administration Staff From Food and Drug Administration (FDA) πΊπΈ This document is a guidance document titled "Compliance Policy for Combination Product Postmarketing Safety Reporting" for 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 filled Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 66.66666666666666/100 Updated on May 7, 2020 Other (Public Domain) 0 reuses 0 favorites
How to Prepare a Pre-Request for Designation (Pre-RFD): Guidance for Industry From Food and Drug Administration (FDA) πΊπΈ Learn how to prepare a Pre-Request for Designation (Pre-RFD) with this industry guidance document on Combination 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 January 21, 2020 Other (Public Domain) 0 reuses 0 favorites
Evaluation of Devices Used with Regenerative Medicine Advanced Therapies: Guidance for Industry From Food and Drug Administration (FDA) πΊπΈ This document is a guidance for the evaluation of devices used with regenerative medicine advanced therapies, focusing on combination 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 29, 2019 Other (Public Domain) 0 reuses 0 favorites