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Jul 13

New FDA Guidances for May and June 2016

By Yuka Fukushima, Regulatory Associate & Compliance Specialist at Cato Research
FDA draft and final guidances, released from CDER, CBER, and CDRH from May-June 2016, are posted.  In addition, upcoming advisory committee meetings to be held are also listed below with a link to more information.

Special Interest Guidances/Information Date Posted
Early Clinical Trials With Live Biotherapeutic Products: Chemistry, Manufacturing, and Control Information – Final Guidance 6/30/2016
Recurrent Herpes Labialis: Developing Drugs for Treatment and Prevention – Draft Guidance 6/30/2016
Vulvovaginal Candidiasis: Developing Drugs for Treatment – Draft Guidance 6/30/2016
Elemental Impurities in Drug Products – Draft Guidance 6/30/2016
Procedures for Evaluating Appearance Issues and Granting Authorizations for Participation in FDA Advisory Committees – Draft Guidance 6/28/2016
FDA Regional Implementation Specifications for ICH E2B(R3) Reporting to the FDA Adverse Event Reporting System (FAERS) – Technical Specifications Document 6/22/2016
Leveraging Existing Clinical Data for Extrapolation to Pediatric Uses of Medical Devices – Final Guidance 6/21/2016
Evaluation and Reporting of Age, Race, and Ethnicity Data in Medical Device Clinical Studies – Draft Guidance for Industry and Food and Drug Administration Staff – Draft Guidance 6/20/2016
Use of International Standard ISO 10993-1, Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process – Final Guidance 6/16/2016
Factors to Consider Regarding Benefit-Risk in Medical Device Product Availability, Compliance, and Enforcement Decisions – Draft Guidance 6/16/2016
Quality Attribute Considerations for Chewable Tablets – Draft Guidance 6/16/2016
Osteoporosis: Nonclinical Evaluation of Drugs Intended for Treatment – Draft Guidance 6/13/2016
Dissemination of Patient-Specific Information from Devices by Device Manufacturers – Draft Guidance 6/10/2016
Policy on Compounding Using Bulk Drug Substances Under Section 503B of the Federal Food, Drug, and Cosmetic Act – Final Guidance 6/9/2016
Interim Policy on Compounding Using Bulk Drug Substances Under Section 503A of the Federal Food, Drug, and Cosmetic Act Guidance for Industry – Final Guidance 6/9/2016
Pharmacy Compounding of Human Drug Products Under Section 503A of the Federal Food, Drug, and Cosmetic Act Guidance – Final Guidance 6/9/2016
E18 Genomic Sampling and Management of Genomic Data – Draft Guidance 6/2/2016
Individual Patient Expanded Access Applications: Form FDA 3926 – Final Guidance 6/2/2016
Charging for Investigational Drugs Under an IND — Qs & As – Final Guidance 6/2/2016
Expanded Access to Investigational Drugs for Treatment Use — Qs & As – Final Guidance 6/2/2016
FDA Categorization of Investigational Device Exemption (IDE) Devices to Assist the Centers for Medicare and Medicaid Services (CMS) with Coverage Decisions – Draft Guidance 6/1/2016
Assessing Adhesion with Transdermal Delivery Systems and Topical Patches for ANDAs – Draft Guidance 5/31/2016
Implementation of Acceptable Full-Length and Abbreviated Donor History Questionnaires and Accompanying Materials for Use in Screening Donors of Blood and Blood Components – Final Guidance 5/27/2016
Chronic Obstructive Pulmonary Disease: Developing Drugs for Treatment – Draft Guidance 5/19/2016
Use of Electronic Health Record Data in Clinical Investigations – Draft Guidance 5/16/2016
Postmarket Surveillance Under Section 522 of the Federal Food, Drug, and Cosmetic Act – Final Guidance 5/16/2016
Considerations for Use of Histopathology and Its Associated Methodologies to Support Biomarker Qualification – Final Guidance 5/13/2016
Infectious Disease Next Generation Sequencing Based Diagnostic Devices: Microbial Identification and Detection of Antimicrobial Resistance and Virulence Markers – Draft Guidance 5/13/2016
Technical Considerations for Additive Manufactured Devices – Draft Guidance 5/10/2016
Chronic Hepatitis C Virus Infection: Developing Direct-Acting Antiviral Agents for Treatment – Draft Guidance 5/3/2016
Special Protocol Assessment – Draft Guidance 5/3/2016
Upcoming Meetings (* = New)
* Arthritis Advisory Committee Meeting – 12 July, Silver Spring, MD
* Arthritis Advisory Committee Meeting – 13 July, Silver Spring, MD
* Meeting of the Dermatologic and Ophthalmic Drugs Advisory Committee Meeting – 19 July, Silver Spring, MD
* Clinical Chemistry and Clinical Toxicology Devices Panel of the Medical Devices Advisory Committee Meeting – 21-22 July, Gaithersburg, MD
* Cellular, Tissue, and Gene Therapies Advisory Committee Meeting – 26 July, Silver Spring, MD
* Clinical Chemistry and Clinical Toxicology Devices Panel of the Medical Devices Advisory Committee Meeting – 10 August, Gaithersburg, MD
* Microbiology Devices Panel of the Medical Devices Advisory Committee Meeting – 16 August, Silver Spring, MD
Joint Meeting of the Anesthetic and Analgesic Drug Products Advisory Committee, the Drug Safety and Risk Management Advisory Committee, and the Pediatric Advisory Committee Meeting, 15-16 September, Silver Spring, MD
* Meeting of the Bone, Reproductive and Urologic Drugs Advisory Committee – 19 October, Silver Spring, MD

* new entry
Last updated: 08 July 2016