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Dec 11

New FDA Guidances for November 2018

By Joanne McNelis, Ph.D., RAC (US), Clinical Strategy Scientist II at Cato Research

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

 

Special Interest Guidances/Information Date Posted
Self-Monitoring Blood Glucose Test Systems for Over-the-Counter Use – Draft Guidance 30 Nov 2018
Blood Glucose Monitoring Test Systems for Prescription Point-of-Care Use – Draft Guidance 30 Nov 2018
Recommendations for Dual 510(k) and CLIA Waiver by Application Studies – Draft Guidance 29 Nov 2018
Nonmetastatic, Castration-Resistant Prostate Cancer: Considerations for Metastasis-Free Survival Endpoint in Clinical Trials – Draft Guidance 13 Nov 2018
Meta-Analyses of Randomized Controlled Clinical Trials to Evaluate the Safety of Human Drugs or Biological Products Guidance for Industry – Draft Guidance 06 Nov 2018
Hypertension: Developing Fixed-Dose Combination Drugs for Treatment Guidance for Industry – Final Guidance 06 Nov 2018
Unique Device Identification: Policy Regarding Compliance Dates for Class I and Unclassified Devices and Certain Devices Requiring Direct Marking – Immediately in Effect Guidance for Industry and Food and Drug Administration Staff – Final Guidance 05 Nov 2018
Chronic Hepatitis B Virus Infection: Developing Drugs for Treatment – Draft Guidance 01 Nov 2018
Upcoming Meetings (* = New)
December 17-18, 2018: Joint Meeting of the Anesthetic and Analgesic Drug Products Advisory Committee and the Drug Safety and Risk Management Advisory Committee Meeting Announcement
* January 11, 2019: Joint Meeting of the Arthritis Advisory Committee and the Drug Safety and Risk Management Advisory Committee Meeting Announcement
* January 16, 2019: Meeting of the Bone, Reproductive and Urologic Drugs Advisory Committee Meeting Announcement
* January 17, 2019: Meeting of the Endocrinologic and Metabolic Drugs Advisory Committee Meeting Announcement
Last updated: 07 November 2018