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May 07

New FDA Guidances for April 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
Multiple Function Device Products: Policy and Considerations – Draft Guidance for Industry and Food and Drug Administration – Draft Guidance 27 Apr 2018
Clinical Trial Imaging Endpoint Process Standards Guidance for Industry – Final Guidance 26 Apr 2018
Severely Debilitating or Life-Threatening Hematologic Disorders: Nonclinical Development of Pharmaceuticals Guidance for Industry – Draft Guidance 23 Apr 2018
Submitting Study Datasets for Vaccines to the Office of Vaccines Research and Review; Guidance for Industry; Technical Specifications Document – Draft Guidance 20 Apr 2018
Opioid Dependence: Developing Depot Buprenorphine Products for Treatment – Draft Guidance 20 Apr 2018
Q7 Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients Questions and Answers Guidance for Industry – Final Guidance 19 Apr 2018
Metered Dose Inhaler (MDI) and Dry Powder Inhaler (DPI) Drug Products–Quality Considerations – Draft Guidance (revised) 18 Apr 2018
Investigational In Vitro Diagnostics in Oncology Trials: Streamlined Submission Process for Study Risk Determination; Draft Guidance for Industry – Draft Guidance 16 Apr 2018
Expansion of the Abbreviated 510(k) Program: Demonstrating Substantial Equivalence through Performance Criteria; Draft Guidance for Industry and Food and Drug Administration – Draft Guidance 12 Apr 2018
Special Protocol Assessment Guidance for Industry – Final Guidance 12 Apr 2018
Investigational In Vitro Diagnostics in Oncology Trials: Streamlined Submission Process for Study Risk Determination Guidance for Industry – Draft Guidance 12 Apr 2018
E11(R1) Addendum: Clinical Investigation of Medicinal Products in the Pediatric Population – Final Guidance 10 Apr 2018
Pregnant Women: Scientific and Ethical Considerations for Inclusion in Clinical Trials – Draft Guidance  06 Apr 2018
Atopic Dermatitis: Timing of Pediatric Studies During Development of Systemic Drugs – Draft Guidance 06 Apr 2018
Liposome Drug Products: Chemistry, Manufacturing, and Controls; Human Pharmacokinetics and Bioavailability; and Labeling Documentation – Final Guidance 04 Apr 2018
Upcoming Meetings (* = New)
  April 19, 2018: Meeting of the Peripheral and Central Nervous System Drugs Advisory Committee Meeting Announcement
  April 23, 2018: Arthritis Advisory Committee Meeting
  April 24-25, 2018: Joint Meeting of the Arthritis Advisory Committee and the Drug Safety and Risk Management Advisory Committee Meeting Announcement
  May 2, 2018: Antimicrobial Drugs Advisory Committee Meeting Announcement
  May 3, 2018: Joint Meeting of the Gastrointestinal Drugs Advisory Committee and the Pediatric Advisory Committee Meeting Announcement
  May 10, 2018: Endocrinologic and Metabolic Drugs Advisory Committee Meeting Announcement
* May 11, 2018: Joint Meeting of the Pediatric Advisory Committee and the Endocrinologic and Metabolic Drugs Advisory Committee Meeting Announcement
  May 22, 2018: Joint Meeting of the Anesthetic and Analgesic Drug Products Advisory Committee and the Drug Safety and Risk Management Advisory Committee Meeting Announcement
Last updated: 03 May 2018