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Aug 04 2015

New FDA Guidances for July 2015

By Brant Hamel, Ph.D., Regulatory Scientist at Cato Research


FDA draft and final guidances, released from CDER, CBER, and CDRH in July 2015, are posted.  In addition, upcoming advisory committee meetings to be held in September are also listed below with a link to more information.

Special Interest Guidances/Information Date Posted
Dissolution Testing and Specification Criteria for Immediate-Release Solid Oral Dosage Forms Containing Biopharmaceutics Classification System Class 1 and 3 Drugs – Draft Guidance 31 Jul 2015
Recommendations for Premarket Notification (510(k)) Submissions for Nucleic Acid-Based Human Leukocyte Antigen (HLA) Test Kits Used for Matching of Donors and Recipients in Transfusion and Transplantation – Final Guidance 31 Jul 2015
Request for Quality Metrics Guidance for Industry – Draft Guidance 27 Jul 2015
Analytical Procedures and Methods Validation for Drugs and Biologics – Draft Guidance 24 Jul 2015
Gastroparesis: Clinical Evaluation of Drugs for Treatment – Draft Guidance 22 Jul 2015
Testicular Toxicity: Evaluation During Drug Development – Draft Guidance 16 Jul 2015
Submission of Premarket Notifications for Magnetic Resonance Diagnostic Devices – Draft Guidance 14 Jul 2015
Heparin-Containing Medical Devices and Combination Products: Recommendations for Labeling and Safety Testing – Draft Guidance 09 Jul 2015
Qualification of Biomarker–Plasma Fibrinogen in Studies Examining Exacerbations and/or All-Cause Mortality in Patients With Chronic Obstructive Pulmonary Disease – Draft Guidance 02 Jul 2015
Intent to Exempt Certain Unclassified, Class II, and Class I Reserved Medical Devices from Premarket Notification Requirements – Final Guidance 01 Jul 2015
Upcoming Meetings (* = New)
* Vaccines and Related Biological Products Advisory Committee Meeting, 15 September 2015; Silver Spring, MD
* Obstetrics and Gynecology Devices Panel of the Medical Devices Advisory Committee Meeting Announcement, 24 September 2015; Silver Spring, MD

* new entry

Last updated: 03 August 2015