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Aug 16

New FDA Guidances for June and July 2018

By Joanne McNelis, PhD, RAC (US), Scientist at Cato Research

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

 

Special Interest Guidances/Information Date Posted
Recommendations for Reducing the Risk of Transfusion-Transmitted Babesiosis; Draft Guidance for Industry – Draft Guidance 27 July 2018
Peripheral Vascular Atherectomy Devices – Premarket Notification [510(k)] Submissions – Draft Guidance 27 July 2018
Slowly Progressive, Low-Prevalence Rare Diseases with Substrate Deposition That Results from Single Enzyme Defects: Providing Evidence of Effectiveness for Replacement or Corrective Therapies Guidance for Industry – Draft Guidance 26 July 2018
Use of Liquids and/or Soft Foods as Vehicles for Drug Administration: General Considerations for Selection and In Vitro Methods for Product Quality Assessments – Draft Guidance 24 July 2018
Inborn Errors of Metabolism That Use Dietary Management: Considerations for Optimizing and Standardizing Diet in Clinical Trials for Drug Product Development: Guidance for Industry – Draft Guidance 23 July 2018
E17 General Principles for Planning and Design of Multi-Regional Clinical Trials – Final Guidance 18 July 2018
Use of Electronic Health Record Data in Clinical Investigations Guidance for Industry – Final Guidance 18 July 2018
Labeling for Biosimilar Products Guidance for Industry – Final Guidance 18 July 2018
Field Alert Report Submission: Questions and Answers Guidance for Industry – Draft Guidance 18 July 2018
Metal Expandable Biliary Stents – Premarket Notification (510(k)) Submissions – Draft Guidance 18 July 2018
Innovative Approaches for Nonprescription Drug Products – Draft Guidance 17 July 2018
Q3D(R1) ELEMENTAL IMPURITIES – Draft Guidance 13 July 2018
Testing of Retroviral Vector-Based Human Gene Therapy Products for Replication Competent Retrovirus During Product Manufacture and Patient Follow-up; Draft Guidance for Industry – Draft Guidance 11 July 2018
Chemistry, Manufacturing, and Control (CMC) Information for Human Gene Therapy Investigational New Drug Applications (INDs); Draft Guidance for Industry – Draft Guidance 11 July 2018
Long Term Follow-up After Administration of Human Gene Therapy Products; Draft Guidance for Industry – Draft Guidance 11 July 2018
Human Gene Therapy for Hemophilia; Draft Guidance for Industry – Draft Guidance 11 July 2018
Human Gene Therapy for Rare Diseases; Draft Guidance for Industry – Draft Guidance 11 July 2018
Human Gene Therapy for Retinal Disorders; Draft Guidance for Industry – Draft Guidance 11 July 2018
Smallpox (Variola) Infection: Developing Drugs for Treatment or Prevention – Draft Guidance 10 July 2018
Revised Recommendations for Reducing the Risk of Zika Virus Transmission by Blood and Blood Components; Guidance for Industry – Final Guidance 09 July 2018
Indications and Usage Section of Labeling for Human Prescription Drug and Biological Products — Content and Format Guidance for Industry – Draft Guidance 06 July 2018
ANDA Submissions — Amendments to Abbreviated New Drug Applications Under GDUFA – Final Guidance 03 July 2018
Oncology Therapeutic Radiopharmaceuticals: Nonclinical Studies and Labeling Recommendations Guidance for Industry – Draft Guidance 28 Jun 2018
Assessing User Fees Under the Biosimilar User Fee Amendments of 2017 Guidance for Industry – Final Guidance 28 Jun 2018
Major Depressive Disorder: Developing Drugs for Treatment – Draft Guidance 20 Jun 2018
Prescription Drug User Fee Act Waivers, Reductions, and Refunds for Drug and Biological Products Guidance for Industry – Draft Guidance 20 Jun 2018
Logical Observation Identifiers Names and Codes for In Vitro Diagnostic Tests – Guidance for Industry and Food and Drug Administration Staff – Draft Guidance 15 Jun 2018
Coronary, Peripheral, and Neurovascular Guidewires – Performance Tests and Recommended Labeling – Draft Guidance 15 Jun 2018
Intravascular Catheters, Wires, and Delivery Systems with Lubricious Coatings – Labeling Considerations – Draft Guidance 15 Jun 2018
Epidermolysis Bullosa: Developing Drugs for Treatment of Cutaneous Manifestations; Draft Guidance for Industry – Draft Guidance 15 Jun 2018
S9 Nonclinical Evaluation for Anticancer Pharmaceuticals–Questions and Answers – Final Guidance 15 Jun 2018
Humanitarian Device Exemption (HDE) Program – Draft Guidance 15 Jun 2018
Human Immunodeficiency Virus-1 Infection: Developing Systemic Drug Products for Pre-Exposure Prophylaxis – Draft Guidance 13 Jun 2018
Limited Population Pathway for Antibacterial and Antifungal Drugs Guidance for Industry – Draft Guidance 12 Jun 2018
Patient-Focused Drug Development: Collecting Comprehensive and Representative Input – Draft Guidance 12 Jun 2018
Medical Product Communications That Are Consistent With the FDA-Required Labeling — Questions and Answers Guidance for Industry – Final Guidance 12 Jun 2018
Drug and Device Manufacturer Communications With Payors, Formulary Committees, and Similar Entities – Questions and Answers Guidance for Industry and Review Staff – Final Guidance 12 Jun 2018
Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program – Draft Guidance 07 Jun 2018
Prescription Drug User Fee Act Waivers for Fixed-Combination Antiretroviral Drugs for the President’s Emergency Plan for AIDS Relief – Draft Guidance 06 Jun 2018
Formal Meetings Between the FDA and Sponsors or Applicants of BsUFA Products Guidance for Industry – Draft Guidance 04 Jun 2018
Considerations for the Inclusion of Adolescent Patients in Adult Oncology Clinical Trials – Draft Guidance 01 Jun 2018
Complicated Urinary Tract Infections: Developing Drugs for Treatment – Final Guidance 01 Jun 2018
Upcoming Meetings (* = New)  
* September 20, 2018: Meeting of the Pharmaceutical Science and Clinical Pharmacology Advisory Committee Meeting Announcement
Last updated: 15 August 2018