CPG Sec. 160.750 Drug and Device Products (Including Biologics and Animal Drugs) Found in Violation of GMPRs - Reconditioning From Food and Drug Administration (FDA) 🇺🇸 This document is a Compliance Policy Guide (CPG) titled "CPG Sec. 160.750 Drug and Device Products Found in Violation of GMPRs - Reconditioning". 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
User Fees and Refunds for Premarket Approval Applications and Device Biologics License Applications: Guidance for Industry and Food and Drug Administration Staff From Food and Drug Administration (FDA) 🇺🇸 This document provides guidance on user fees and refunds for premarket approval applications and device biologics license 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 October 19, 2022 Other (Public Domain) 0 reuses 0 favorites
Food and Drug Administration Regulations; Change of Addresses; Technical Amendment From Food and Drug Administration (FDA) 🇺🇸 Document number 2015-07268. The Food and Drug Administration (FDA) is amending its regulations to update address information for the Center for Biologics Evaluation and Research (CBER) as a result of the recent relocation of CBER offices and laboratories to the FDA White Oak campus in Silver… 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 3, 2015 Other (Public Domain) 0 reuses 0 favorites
Notice - Revision to Guidance Document: Submission of Pharmacogenomic Information From Health Canada 🇨🇦 Provides guidance on how and when to submit pharmacogenomic information to Health Canada, in support of an application or submission for a drug, biologic drug, or medical device intended for human use, or as part of ongoing post-market activities 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 13, 2008 Open Government License 2.0 (Canada) 0 reuses 0 favorites
Use of Materials Derived from Cattle in Medical Products Intended for Use in Humans and Drugs Intended for Use in Ruminants From Food and Drug Administration (FDA) 🇺🇸 Document number E6-22329. The Food and Drug Administration (FDA) is proposing to prohibit the use of certain cattle material in, or in the manufacture (including processing) of, drugs, biologics, and medical devices intended for use in humans and human cells, tissues, and cellular and tissue-based… 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 12, 2007 Other (Public Domain) 0 reuses 0 favorites
Operations Related to Compensation System for Infections and Other Damages Caused by Biologics From Pharmaceuticals and Medical Devices Agency (PMDA) 🇯🇵 This document outlines operations for compensating health damage caused by biologics, focusing on the compensation system for infections and other damages. 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 10, 2024 Other (Public Domain) 0 reuses 0 favorites