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Nov 06 2019

New FDA Guidances for October 2019 and Upcoming Adcom Meetings

By Sheila Plant, PhD, MHS, RAC (US), Director, Regulatory Strategy at Cato Research

Special Interest Guidances/Information Date Posted
Assessing User Fees Under the Generic Drug User Fee Amendments of 2017 – Draft Guidance 01 November 2019
Chronic Hepatitis D Virus Infection: Developing Drugs for Treatment Guidance for Industry – Draft Guidance 01 November 2019
Electronic Submission of IND Safety Reports Technical Conformance Guide : Guidance for Industry – Final Guidance 30 October 2019
Providing Regulatory Submissions in Electronic Format: IND Safety Reports: Guidance for Industry – Draft Guidance 30 October 2019
Type V DMFs for CDER-Led Combination Products Using Device Constituent Parts With Electronics or Software Guidance for Industry – Draft Guidance 28 October 2019
Breast Implants – Certain Labeling Recommendations to Improve Patient Communication: Draft Draft Guidance for Industry and Food and Drug Administration Staff – Draft Guidance 24 October 2019
Drug Products Labeled as Homeopathic Guidance for FDA Staff and Industry: Draft Revised Draft – Draft Guidance 24 October 2019
Postmarketing Studies and Clinical Trials—Implementation of Section 505(o)(3) of the Federal Food, Drug, and Cosmetic Act Guidance for Industry – Draft Guidance 24 October 2019
Identification of Manufacturing Establishments in Applications Submitted to CBER and CDER Questions and Answers – Final Guidance 22 October 2019
Drug Master Files Guidance for Industry – Draft Guidance 18 October 2019
Prescription Drug User Fee Act Waivers, Reductions, and Refunds for Drug and Biological Products Guidance for Industry – Final Guidance 16 October 2019
Submitting Study Datasets for Vaccines to the Office of Vaccines Research and Review: Guidance for Industry; Technical Specifications Document – Final Guidance 15 October 2019
Coronary, Peripheral, and Neurovascular Guidewires – Performance Tests and Recommended Labeling: Guidance for Industry and Food and Drug Administration Staff – Final Guidance 10 October 2019
Intravascular Catheters, Wires, and Delivery Systems with Lubricious Coatings – Labeling Considerations: Guidance for Industry and Food and Drug Administration Staff – Final Guidance 10 October 2019
Investigational In Vitro Diagnostics in Oncology Trials: Streamlined Submission Process for Study Risk Determination Guidance for Industry – Final Guidance 09 October 2019
Further Testing of Donations that are Reactive on a Licensed Donor Screening Test for Antibodies to Hepatitis C Virus: Guidance for Industry – Final Guidance 02 October 2019
Investigational Enzyme Replacement Therapy Products: Nonclinical Assessment: Guidance for Industry – Final Guidance 02 October 2019
Bacterial Risk Control Strategies for Blood Collection Establishments and Transfusion Services to Enhance the Safety and Availability of Platelets for Transfusion: Guidance for Industry – Final Guidance 30 September 2019
   
Upcoming Meetings (* = New)
  November 6-7, 2019: General Hospital and Personal Use Devices Panel of the Medical Devices Advisory Committee Meeting
  November 8, 2019: Vaccines and Related Biological Products Advisory Committee Meeting
  November 13, 2019: Meeting of the Endocrinologic and Metabolic Drugs Advisory Committee Meeting
  November 13-14, 2019: Immunology Devices Panel of the Medical Devices Advisory Committee Meeting
* November 14, 2019: Meeting of the Endocrinologic and Metabolic Drugs Advisory Committee Meeting
* Blood Products Advisory Committee November 22, 2019 Meeting

   Last updated: 05 November 2019