New FDA Guidances for September 2017

By Michelle Villasmil, Ph.D., RAC (US), Regulatory Scientist at Cato Research

FDA draft and final guidances released from CDER, CBER, and CDRH and Manual of Policies and Procedures (MAPPs) of interest released from CDER in September 2017 are posted. In addition, upcoming advisory committee meetings are listed below with links to more information.

 

Special Interest Guidances/Information Date Posted
Developing and Responding to Deficiencies in Accordance with the Least Burdensome Provisions – Final Guidance 29 Sep 2017
Center for Devices and Radiological Health Appeals Processes: Questions and Answers About 517A – Final Guidance 29 Sep 2017
Display Devices for Diagnostic Radiology – Final Guidance 29 Sep 2017
Administrative Procedures for CLIA Categorization – Final Guidance 29 Sep 2017
Oncology Pharmaceuticals: Reproductive Toxicity Testing and Labeling Recommendations – Draft Guidance 28 Sep 2017
Advancement of Emerging Technology Applications for Pharmaceutical Innovation and Modernization – Final Guidance 28 Sep 2017
Classification of Products as Drugs and Devices and Additional Product Classification Issues – Final Guidance 25 Sep 2017
Expedited Programs for Serious Conditions – Drugs and Biologics – Final Guidance 22 Sep 2017
Statistical Approaches to Evaluate Analytical Similarity – Draft Guidance 21 Sep 2017
Q4B Annex I: Residue on Ignition/Sulphated Ash General Chapter – Final Guidance 18 Sep 2017
Q4B Annex 2: Test for Extractable Volume of Parenteral Preparations General Chapter – Final Guidance 18 Sep 2017
Q4B Annex 3: Test for Particulate Contamination: Subvisible Particles General Chapter – Final Guidance 18 Sep 2017
Q4B Annex 4A: Microbiological Examination of Non-Sterile Products: Microbial Enumeration Tests General Chapter – Final Guidance 18 Sep 2017
Q4B Annex 4B: Microbiological Examination of Non-Sterile Products: Tests for Specified Micro-organisms General Chapter – Final Guidance 18 Sep 2017
Q4B Annex 4C: Microbiological Examination of Non-Sterile Products: Acceptance Criteria for Pharmaceutical Preparations and Substances for Pharmaceutical Use General Chapter – Final Guidance 18 Sep 2017
Q4B Annex 5: Disintegration Test General Chapter – Final Guidance 18 Sep 2017
Q4B Annex 8: Sterility Test General Chapter – Final Guidance 18 Sep 2017
Q4B Annex 9: Tablet Friability General Chapter – Final Guidance 18 Sep 2017
Q4B Annex 10: Polyacrylamide Gel Electrophoresis General Chapter – Final Guidance 18 Sep 2017
Establishing the Performance Characteristics of In Vitro Diagnostic Devices for the Detection or Detection and Differentiation of Human Papillomaviruses – Final Guidance 15 Sep 2017
Regulatory Considerations for Microneedling Devices – Draft Guidance 15 Sep 2017
Utilizing Animal Studies to Evaluate Organ Preservation Devices – Draft Guidance 12 Sep 2017
Microdose Radiopharmaceutical Diagnostic Drugs: Nonclinical Study Recommendations – Draft Guidance 12 Sep 2017
Evaluation and Reporting of Age-, Race-, and Ethnicity-Specific Data in Medical Device Clinical Studies – Final Guidance 12 Sep 2017
Guidance Agenda: Guidances CDER is Planning… 12 Sep 2017
Design Considerations and Pre-market Submission Recommendations for Interoperable Medical Devices – Final Guidance 06 Sep 2017
Deviation Reporting for Human Cells, Tissues, and Cellular and Tissue-Based Products Regulated Solely Under Section 361 of the Public Health Service Act and 21 CFR Part 1271 – Final Guidance 06 Sep 2017
Procedures for Meetings of the Medical Devices Advisory Committee – Final Guidance 01 Sep 2017
Requalification of Donors Previously Deferred for a History of Viral Hepatitis after the 11th Birthday – Final Guidance 01 Sep 2017
Providing Regulatory Submissions in Electronic Format – Content of the Risk Evaluation and Mitigation Strategies Document Using Structured Product Labeling – Draft Guidance 01 Sep 2017
Special Interest Manual of Policies & Procedures (CDER) Date Posted
Process for Evaluating Emerging Technologies Related to Quality 28 Sep 2017
Environmental Assessments and Claims of Categorical Exclusion 14 Sep 2017
Filing Review of Abbreviated New Drug Applications 01 Sep 2017
Upcoming Meetings (* = New)
* October 4, 2017: Vaccines and Related Biological Products Advisory Committee
  October 11-12, 2017: Patient Engagement Advisory Committee
* October 12, 2017: Cellular, Tissue and Gene Therapies Advisory Committee
* October 13, 2017: Meeting of the Dermatologic and Ophthalmic Drugs Advisory Committee
* October 31, 2017: Joint Meeting of the Psychopharmacologic Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee
* November 1, 2017: Joint Meeting of the Psychopharmacologic Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee
* November 7, 2017: Vaccines and Related Biological Products Advisory Committee
* November 16, 2017: Meeting of the Antimicrobial Drugs Advisory Committee
  December 7, 2017: Meeting of the Bone, Reproductive and Urologic Drugs Advisory Committee
Last updated: 03 October 2017
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