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Mar 31 2014

New FDA Guidances for March 2014

By Sheila R. Plant, Ph.D., R.A.C., Regulatory Scientist at Cato Research

FDA draft and final guidances, released from CDER, CBER, and CDRH in March, are posted.  In addition, upcoming Advisory committee meetings, other public meetings hosted by FDA, as well as CDRH’s 2014 Strategic Priorities are listed below with links to more information on each.

 

Special Interest Guidances/Information

Date Posted

Fees for Human Drug Compounding Outsourcing Facilities Under Sections 503B and 744K of the FD&C Act – Draft Guidance

31 Mar 2014

Medical Device Tracking – Final Guidance; supersedes 25 Jan 2010 guidance

27 Mar 2014

Premarket Assessment of Pediatric Medical Devices– Final Guidance; supersedes 14 May 2004 guidance

24 Mar 2014

Labeling for Human Prescription Drug and Biological Products Approved Under the Accelerated Approval Regulatory Pathway – Draft Guidance

24 Mar 2014

Premarket Notification [510(k)] Submissions for Bipolar Electrosurgical Vessel Sealers for General Surgery – Draft Guidance

24 Mar 2014

Premarket Notification [510(k)] Submissions for Electrosurgical Devices for General Surgery – Draft Guidance

24 Mar 2014

Humanitarian Device Exemption (HDE): Questions and Answers – Draft Guidance

18 Mar 2014

Bioavailability and Bioequivalence Studies Submitted in NDAs or INDs — General Considerations – Draft Guidance

17 Mar 2014

Allowable Excess Volume and Labeled Vial Fill Size in Injectable Drug and Biological Products – Draft Guidance

13 Mar 2014

Administrative Procedures for CLIA Categorization – Final Guidance, supersedes 7 May 2008 guidance

12 Mar 2014

Chronic Fatigue Syndrome/Myalgic Encephalomyelitis: Developing Drug Products for Treatment – Draft Guidance

10 Mar 2014

BLA for Minimally Manipulated, Unrelated Allogeneic Placental/Umbilical Cord Blood Intended for Hematopoietic and Immunologic Reconstitution in Patients with Disorders Affecting the Hematopoietic System – Final Guidance

5 Mar 2014

IND Applications for Minimally Manipulated, Unrelated Allogeneic Placental/Umbilical Cord Blood Intended for Hematopoietic and Immunologic Reconstitution in Patients with Disorders Affecting the Hematopoietic System – Final Guidance

5 Mar 2014

CDRH 2014 Strategic Priorities

5 Feb 2014

Upcoming Meetings (* = New)

* Endocrinologic and Metabolic Drugs Advisory Committee Meeting; 1Apr 2014, Hyattsville, MD
* Anesthetic and Analgesic Drug Products Advisory Committee Meeting Announcement; 22Apr 2014, Silver Spring, MD
* Neurological Devices Panel of the Medical Devices Advisory Committee Meeting; 24Apr2014, Gaithersburg, MD
* May 5, 2014: Risk Communication Advisory Committee Meeting Announcement; 5May2014, Silver Spring, MD
* Public Hearing on the Food and Drug Administration Safety and Innovation Act (FDASIA) Section 907; 1Apr2014, Silver Spring, MD
* Public Meeting on Pulmonary Arterial Hypertension Patient-Focused Drug Development, 13May  2014, Silver Spring, MD
* Public Workshop – Advancing Regulatory Science for High Throughput Sequencing Devices for Microbial Identification and Detection of Antimicrobial Resistance Markers; 1Apr2014, Silver Spring, MD
* Public Workshop – Methods for Thrombogenicity Testing; 14Apr2014, Silver Spring, MD