• Director's Corner With Dr. Janet Woodcock:  Looking back on 2016 accomplishments and Moving Forward in 2017.

• Manual of Policies and Procedures (MAPP) 4200.3 Rev.1 Consulting the Controlled Substance Staff on Drug Abuse Potential and Labeling, Drug Scheduling, Dependence Liability and Drug Abuse Risks to the Public Health (PDF -112KB)

• Providing Regulatory Submissions in Electronic Format — Certain Human Pharmaceutical Product Applications and Related Submissions Using the eCTD Specifications Guidance for Industry  (PDF - 115KB)

Update to Guidance

Section I. Introduction

• Paragraph added describing rationale for changing timetable for required master file submissions in eCTD from 24 months to 36 months.

Section III.B. Timetable for Implementation of Electronic Submission Requirements

·         Updated to reflect that the requirement for master files to be filed electronically takes place 36 months after May 5, 2015.

• Important Information for Human Cell, Tissue and Cellular and Tissue-based Product (HCT/P) Establishments Regarding Zika Virus 
  Posted: 3/13/2017

• Important Information for Blood Establishments Regarding Zika Virus 

• Public Workshop: Identification and Characterization of the Infectious Disease Risks of Human Cells, Tissues, and Cellular and Tissue-based Products 
  FR Notice corrected; Posted: 3/21/2017
  • February 8, 2017 Transcript - Identification and Characterization of the Infectious Disease Risks of Human Cells, Tissues, and Cellular and Tissue-based Products (PDF - 2.7MB) 
    Posted: 4/4/2017
  • February 9, 2017 Transcript - Identification and Characterization of the Infectious Disease Risks of Human Cells, Tissues, and Cellular and Tissue-based Products (PDF - 1.4MB) 

• Genetically engineered protein drugs for hemophilia trigger antibody production by binding HLA class II antigens 
  Posted: 3/24/2017

• FDA assay predicts ability of mesenchymal stromal cells to suppress immune system activity 
  Posted: 3/27/2017

• Use of Symbols in Labeling 

The Food and Drug Administration (FDA) issued a final rule, Use of Symbols in Labeling, June 15, 2016, that became effective September 13, 2016. The final rule permits the use of symbols in all medical device labeling without adjacent explanatory text (referred to as "stand-alone symbols") if certain requirements are met. The final rule also specifies that the use of symbols, accompanied by adjacent explanatory text continues to be permitted. The final rule seeks to harmonize the U.S. device labeling requirements for symbols with international regulatory requirements.

Below is a list of resources on the use of symbols in labeling:

·         Final Rule: Use of Symbols in Labeling

·         Frequently Asked Questions

• Presentation and Transcript added to Webinar - Factors to Consider When Making Benefit-Risk Determinations for Medical Device Investigational Device Exemptions Final Guidance - February 23, 2017

·         Presentation (WMV - 11.4MB)

·         Printable Slides (PDF - 273KB)

·         Transcript (PDF - 155KB)

• FDA Webinar - Regulatory Overview for Developers and Sponsors of Neurological Devices: An Introduction to the De Novo Pathway – Wednesday, March 22, 2017

§  Presentation (WMV - 19.5MB)

§  Printable Slides (PDF - 937KB)

§  Transcript (PDF - 274KB)

§  Case Study: Using the De Novo Process to Classify and Bring to Market an Innovative, Low-to-Moderate Risk Device (PDF - 504KB)

• Added Presentation and Transcript to FDA Webinar - Regulatory Overview for Developers and Sponsors of Neurological Devices: An Introduction to the De Novo Pathway – Wednesday, March 22, 2017

• Federal Register: Medical Devices; Exemptions from Premarket Notification: Class II Devices; Request for Comments

SUMMARY: The Food and Drug Administration (FDA or Agency) has  identified a list of class II devices that, when finalized, will be  exempt from premarket notification requirements, subject to certain limitations. FDA is publishing this notice of that determination and requesting public comment. Submit either electronic or written comments on the notice by May 15, 2017. 

• CDRH 2016 Strategic Priorities Update

• Federal Register: Medical Devices; Exemptions From Premarket Notification: Class I Devices

SUMMARY: The Food and Drug Administration (FDA or Agency) has  identified a list of class I devices that are now exempt from premarket  notification requirements, subject to certain limitations. FDA is  publishing this notice of that determination in accordance with  procedures established by the 21st Century Cures Act.

• Public Workshop - Cybersecurity of Medical Devices: A Regulatory Science Gap Analysis, May 18-19, 2017

• CDER Small Business and Industry Education Series: Best Practices for Communication Between FDA and IND Sponsors During Drug Development 
  The course describes best practices and procedures for timely, transparent, and effective communications between investigational new drug application (IND) sponsors and FDA at critical junctures in drug development. 

• Dear Health Care Provider Letters: Improving Communication of Important Safety Information [Guidance for Industry] (PDF - 128KB)

• Manual of Policies and Procedures: 6030.9 Good Review Practice: Good Review Management Principles and Practices for Effective IND Development and Review (PDF - 325KB)

• Guidance Agenda: New & Revised Draft Guidances CDER is Planning to Publish During Calendar Year 2017 (PDF - 46KB)

• Q11 Development and Manufacture of Drug Substances—Questions and Answers (regarding the selection and justification of starting materials. (PDF - 214KB)

Recommendations for Assessment of Blood Donor Eligibility, Donor Deferral and Blood Product Management in Response to Ebola Virus; Guidance for Industry (PDF - 99KB)

We, FDA, are notifying you, blood establishments that collect blood and blood components for transfusion or further manufacture, including Source Plasma, that we have determined Ebola virus to be a transfusion-transmitted infection (TTI) under Title 21 of the Code of Federal Regulations (CFR) 630.3(l). We are also providing you with recommendations for assessing blood donor eligibility, donor deferral and blood product management in the event that an outbreak of Ebola virus disease (EVD) with widespread transmission occurs in at least one country.

Guidance Agenda: Guidance DocumentsCBER is Planning to Publish During Calendar Year 2017 (PDF - 25KB)

This is the list of guidance topics CBER is considering for development during Calendar Year 2017. The list includes topics that currently have no guidance associated with them, topics where updated guidance may be helpful, and topics for which CBER has already issued Level 1 drafts that may be finalized following review of public comments. We currently intend to develop guidance documents on these topics; however, the Center is neither bound by this list of topics, nor required to issue every guidance document on this list. We are not precluded from developing guidance documents on topics not on this list. This list includes guidance documents CBER issued since the August 2016 Guidance Agenda update.

Regenerative Advanced Therapy Designation

As described in Section 3033 of the 21st Century Cures Act, a drug is eligible for designation as a regenerative advanced therapy (RAT) if:

a.      The drug is a regenerative medicine therapy, which is defined as a cell therapy, therapeutic tissue engineering product, human cell and tissue product, or any combination product using such therapies or products, except for those regulated solely under Section 361 of the Public Health Service Act and part 1271 of Title 21, Code of Federal Regulations;

b.      The drug is intended to treat, modify, reverse, or cure a serious or life-threatening disease or condition; and

c.       Preliminary clinical evidence indicates that the drug has the potential to address unmet medical needs for such disease or condition

Final Agenda: Public Workshop: Identification and Characterization of Infectious Disease Risks of Human Cells, Tissues, and Cellular and Tissue-Based Products (PDF - 214KB)

Public Workshop: Identification and Characterization of Infectious Disease Risks of Human Cells, Tissues, and Cellular and Tissue-Based Products February 8-9, 2017