Circumstances that Constitute Delaying, Denying, Limiting, or Refusing a Drug or Device Inspection: Guidance for Industry From Food and Drug Administration (FDA) 🇺🇸 Guidance document for the industry outlining circumstances constituting delays in drug or device inspections, focusing on postmarket 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 June 21, 2024 Other (Public Domain) 0 reuses 0 favorites
21 CFR Chapter I Subchapter H – Medical Devices – Part 822 Postmarket Surveillance From Food and Drug Administration (FDA) 🇺🇸 This document is a regulation titled "21 CFR Chapter I Subchapter H – Medical Devices – Part 822 Postmarket Surveillance". 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
21 CFR Chapter I Subchapter H – Medical Devices – Part 803 Medical Device Reporting From Food and Drug Administration (FDA) 🇺🇸 This document is a regulation titled "21 CFR Chapter I Subchapter H – Medical Devices – Part 803 Medical Device Reporting". 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 March 31, 2023 Other (Public Domain) 0 reuses 0 favorites
Conditional Marketing Authorisations, exceptional circumstances Marketing Authorisations and national scientific advice From Medicines and Healthcare products Regulatory Agency (MHRA) 🇬🇧 Guidance on Conditional Marketing Authorisations, exceptional circumstances Marketing Authorisations and national scientific advice 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 31, 2020 Open Government Licence 2.0 (United Kingdom) 0 reuses 0 favorites
Clarification of When Products Made or Derived From Tobacco Are Regulated as Drugs, Devices, or Combination Products; Amendments to Regulations Regarding “Intended Uses” From Food and Drug Administration (FDA) 🇺🇸 Document number 2016-31950. The Food and Drug Administration (FDA) is issuing this final rule to describe the circumstances in which a product made or derived from tobacco that is intended for human consumption will be subject to regulation as a drug, device, or a combination product under the… 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 January 9, 2017 Other (Public Domain) 0 reuses 0 favorites
Clarification of When Products Made or Derived From Tobacco Are Regulated as Drugs, Devices, or Combination Products; Amendments to Regulations Regarding “Intended Uses” From Food and Drug Administration (FDA) 🇺🇸 Document number 2015-24313. The Food and Drug Administration (FDA) is proposing regulations to describe the circumstances in which a product made or derived from tobacco that is intended for human consumption will be subject to regulation as a drug, device, or a combination product under the… 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 September 25, 2015 Other (Public Domain) 0 reuses 0 favorites
Exceptions or Alternatives to Labeling Requirements for Products Held by the Strategic National Stockpile From Food and Drug Administration (FDA) 🇺🇸 Document number E7-25165. The Food and Drug Administration (FDA) is issuing regulations to permit FDA Center Directors to grant exceptions or alternatives to certain regulatory labeling requirements applicable to human drugs, biological products, or medical devices that are or will be included in… 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 28, 2007 Other (Public Domain) 0 reuses 0 favorites