Regulatory Submissions in Electronic Format for Biologic Products
FDA has started the transition to a more automated electronic review process for these submissions. (Source: What's New at CBER)
Source: What's New at CBER - December 18, 2017 Category: Biomedical Science Source Type: news
Guidance for Industry: Enforcement Policy Regarding Investigational New Drug Requirements for Use of Fecal Microbiota for Transplantation to Treat Clostridium difficile Infection Not Responsive to Standard Therapies
(Source: What's New at CBER)
Source: What's New at CBER - December 15, 2017 Category: Biomedical Science Source Type: news
Evolving Data Mining System is Designed to Speed Identification of Adverse Events Following Vaccinations
This page is about Evolving Data Mining System is Designed to Speed Identification of Adverse Events Following Vaccinations (Source: What's New at CBER)
Source: What's New at CBER - December 13, 2017 Category: Biomedical Science Source Type: news
Guidance for Industry: Recommendations for Blood Establishments: Training of Back-Up Personnel, Assessment of Blood Donor Suitability and Reporting Certain Changes to an Approved Application
This is the Guidance for Industry: Recommendations for Blood Establishments: Training of Back-Up Personnel, Assessment of Blood Donor Suitability and Reporting Certain Changes to an Approved Application. (Source: What's New at CBER)
Source: What's New at CBER - November 29, 2017 Category: Biomedical Science Source Type: news
Guidance for Industry: Recommendations for Donor Questioning, Deferral, Reentry and Product Management to Reduce the Risk of Transfusion-Transmitted Malaria
(Source: What's New at CBER)
Source: What's New at CBER - November 24, 2017 Category: Biomedical Science Source Type: news
Drug Master Files for CBER-Regulated Products
(Source: What's New at CBER)
Source: What's New at CBER - November 21, 2017 Category: Biomedical Science Source Type: news
SOPP 8001.6: Procedures for Parallel Scientific Advice with European Medicines Agency (EMA)- pdf
This is the CBER SOPP 8001.6: Procedures for Parallel Scientific Advice with European Medicines Agency (EMA). (Source: What's New at CBER)
Source: What's New at CBER - November 20, 2017 Category: Biomedical Science Source Type: news
Guidance for Industry: Considerations for Allogeneic Pancreatic Islet Cell Products
(Source: What's New at CBER)
Source: What's New at CBER - November 9, 2017 Category: Biomedical Science Source Type: news
Guidance for Industry: Preclinical Assessment of Investigational Cellular and Gene Therapy Products
(Source: What's New at CBER)
Source: What's New at CBER - November 9, 2017 Category: Biomedical Science Source Type: news
Guidance for Industry and FDA Staff: IND Applications for Minimally Manipulated, Unrelated Allogeneic Placental/Umbilical Cord Blood Intended for Hematopoietic and Immunologic Reconstitution in Patients with Disorders Affecting the Hematopoietic System
(Source: What's New at CBER)
Source: What's New at CBER - November 9, 2017 Category: Biomedical Science Source Type: news
Draft Guidance for Industry: Same Surgical Procedure Exception under 21 CFR 1271.15(b): Questions and Answers Regarding the Scope of the Exception
(Source: What's New at CBER)
Source: What's New at CBER - November 9, 2017 Category: Biomedical Science Source Type: news
Minimal Manipulation of Human Cells, Tissues, and Cellular and Tissue-Based Products: Draft Guidance
(Source: What's New at CBER)
Source: What's New at CBER - November 9, 2017 Category: Biomedical Science Source Type: news
Determining the Need for and Content of Environmental Assessments for Gene Therapies, Vectored Vaccines, and Related Recombinant Viral or Microbial Products; Guidance for Industry
(Source: What's New at CBER)
Source: What's New at CBER - November 9, 2017 Category: Biomedical Science Source Type: news
Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps) from Adipose Tissue: Regulatory Considerations; Draft Guidance
(Source: What's New at CBER)
Source: What's New at CBER - November 9, 2017 Category: Biomedical Science Source Type: news
Minimal Manipulation of Human Cells, Tissues, and Cellular and Tissue-Based Products: Draft Guidance for Industry and Food and Drug Administration Staff
This is a Draft Guidance for Minimal Manipulation of Human Cells, Tissues, and Cellular and Tissue-Based Products: Draft Guidance for Industry and Food and Drug Administration Staff (Source: What's New at CBER)
Source: What's New at CBER - October 13, 2017 Category: Biomedical Science Source Type: news
