«

»

Jan 05

New FDA Guidances for December 2017

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

FDA draft and final guidances released from CDER, CBER, and CDRH in December 2017 are posted. In addition, upcoming advisory committee meetings are listed below with links to more information.

Special Interest Guidances/Information Date Posted
Labeling for Combined Hormonal Contraceptives – Draft Guidance 29 Dec 2017
Nucleic Acid Testing (NAT) for Human Immunodeficiency Virus Type 1 (HIV-1) and Hepatitis C Virus (HCV): Testing, Product Disposition, and Donor Deferral and Reentry – Final Guidance 28 Dec 2017
Formal Meetings Between the FDA and Sponsors or Applicants of PDUFA Products – Draft Guidance 28 Dec 2017
Best Practices for Communication Between IND Sponsors and FDA During Drug Development – Final Guidance 28 Dec 2017
Implementation of Pathogen Reduction Technology in the Manufacture of Blood Components in Blood Establishments: Questions and Answers – Draft Guidance 26 Dec 2017
Chemistry, Manufacturing, and Controls Changes to an Approved Application: Certain Biological Products– Draft Guidance 21 Dec 2017
Amendment to Revised Preventive Measures to Reduce the Possible Risk of Transmission of Creutzfeldt-Jakob Disease and Variant Creutzfeldt-Jakob Disease by Blood and Blood Products – Draft Guidance 21 Dec 2017
Medical Device Accessories – Describing Accessories and Classification Pathways – Final Guidance 20 Dec 2017
Clarification of Orphan Designation of Drugs and Biologics for Pediatrics – Draft Guidance 19 Dec 2017
Replacement Reagent and Instrument Family Policy for In Vitro Diagnostic Devices – Draft Guidance 19 Dec 2017
Standards Development and the Use of Standards in Regulatory Submissions Reviewed in the Center for Biologics Evaluation and Research – Draft Guidance 18 Dec 2017
Drug Products Labeled as Homeopathic – Draft Guidance 18 Dec 2017
Investigational IVDs Used in Clinical Investigations of Therapeutic Products – Draft Guidance 18 Dec 2017
Developing Targeted Therapies in Low-Frequency Molecular Subsets of a Disease – Draft Guidance 15 Dec 2017
Drug Products, Including Biological Products, that Contain Nanomaterials – Draft Guidance 15 Dec 2017
Information Requests and Discipline Review Letters Under the Generic Drug User Fee Amendments – Draft Guidance 15 Dec 2017
The Least Burdensome Provisions: Concept and Principles – Draft Guidance 15 Dec 2017
An Acceptable Circular of Information for the Use of Human Blood and Blood Components – Final Guidance 14 Dec 2017
Systemic Antibacterial and Antifungal Drugs: Susceptibility Test Interpretive Criteria Labeling for NDAs and ANDAs – Final Guidance 13 Dec 2017
Gluten in Drug Products and Associated Labeling Recommendations – Draft Guidance 12 Dec 2017
Refuse to File: NDA and BLA Submissions to CDER – Draft Guidance 12 Dec 2017
Regulatory Considerations for Human Cell, Tissues, and Cellular and Tissue-Based Products: Minimal Manipulation and Homologous Use – Final Guidance 12 Dec 2017
Product Name Placement, Size, and Prominence in Advertising and Promotional Labeling – Final Guidance 11 Dec 2017
Changes to Existing Medical Software Policies Resulting from Section 3060 of the 21st Century Cures Act – Draft Guidance 08 Dec 2017
Software as a Medical Device (SAMD): Clinical Evaluation – Final Guidance 08 Dec 2017
Clinical and Patient Decision Support Software – Draft Guidance 08 Dec 2017
Pediatric Rare Diseases–A Collaborative Approach for Drug Development Using Gaucher Disease as a Model – Draft Guidance 06 Dec 2017
Use of Serological Tests to Reduce the Risk of Transmission of Trypanosoma cruzi Infection in Blood and Blood Components – Final Guidance 05 Dec 2017
FDA Categorization of Investigational Device Exemption (IDE) Devices to Assist the Centers for Medicare and Medicaid Services (CMS) with Coverage Decisions – Final Guidance 05 Dec 2017
Technical Considerations for Additive Manufactured Medical Devices – Final Guidance 05 Dec 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
Upcoming Meetings (* = New)
* January 9, 2018: Meeting of the Bone, Reproductive and Urologic Drugs Advisory Committee
* January 10, 2018: Meeting of the Bone, Reproductive and Urologic Drugs Advisory Committee
* January 11, 2018: Meeting of the Antimicrobial Drugs Advisory Committee
* January 24, 2018: Tobacco Products Scientific Advisory Committee
* March 1, 2018: Neurological Devices Panel of the Medical Devices Advisory Committee
Last updated: 02 January 2018