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Mar 03 2014

New FDA Guidances for February 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 February, are posted.  In addition, the upcoming Advisory committee meetings and other public meetings hosted by FDA are listed below with links to more information.

Special Interest Guidances/Information

Date Posted

Distributing Scientific and Medical Publications on Unapproved New Uses — Recommended Practices – Revised Draft Guidance

28 Feb 2014

Antiviral Product Development — Conducting and Submitting Virology Studies to the Agency: Guidance for Submitting HIV-1 Resistance Data: Attachment to the Guidance – Draft Guidance

27 Feb 2014

E2B(R3) Electronic Transmission of Individual Case Safety Reports Implementation Guide — Data Elements and Message Specification; and Appendix to the Implementation Guide — Backwards and Forwards Compatibility – Final Guidance

21 Feb 2014

New Chemical Entity Exclusivity Determinations for Certain Fixed-Combination Drug Products – Draft Guidance

21 Feb 2014

Analytical Procedures and Methods Validation for Drugs and Biologics – Draft Guidance

19 Feb 2014

Providing Regulatory Submissions in Electronic Format–Receipt Date – Final Guidance

10 Feb 2014

Analgesic Indications: Developing Drug and Biological Products – Draft Guidance

5 Feb 2014

Providing Regulatory Submissions in Electronic Format — Submissions Under Section 745A(a) of the Federal Food, Drug, and Cosmetic Act– Draft Guidance

5 Feb 2014

Providing Submissions in Electronic Format — Standardized Study Data -Draft Guidance

5 Feb 2014

Requests for Feedback on Medical Device Submissions: The Pre-Submission Program and Meetings with Food and Drug Administration Staff – Final Guidance

18 Feb 2014

Annual Reports for Approved Premarket Approval Applications (PMA) – Final Guidance

10 Feb 2014

Enforcement Policy Regarding Investigational New Drug Requirements for Use of Fecal Microbiota for Transplantation to Treat Clostridium difficile Infection Not Responsive to Standard Therapies – Draft Guidance

March 2014

Requests for Feedback on Medical Device Submissions: The Pre-Submission Program and Meetings with Food and Drug Administration Staff – Final Guidance

18 Feb 2014

Questions and Answers about eMDR – Electronic Medical Device Reporting – Final Guidance

13 Feb 2014

Upcoming Meetings (* = New)

* Pediatric Advisory Committee Meeting; 3Mar 2014; Bethesda, MD
* Public Workshop: Advancing the Development of Pediatric Therapeutics (ADEPT): Pediatric Bone Health; 4 Mar 2014, Bethesda, MD
Over-the-Counter Ophthalmic Drug Products – Emergency Use Eyewash Products; 7 Mar 2014; Silver Spring, MD.
* Microbiology Devices Panel of the Medical Devices Advisory Committee Meeting; 12Mar 2014; College Park MD
Blood Products Advisory Committee Meeting; 18-19 Mar 2014; Silver Spring, MD
* Food and Drug Administration/Xavier University PharmaLink Conference—Leadership in a Global Supply Chain; 19 Mar & 21 Mar 2014, Xavier University, Cincinnati, OH
* Vaccines and Related Biological Products Advisory Committee Meeting; 20 Mar 2014; Rockville, MD
* Regulatory Science and Sustainable Implementation of National and International Medical Device Registries; 24 Mar 2014; San Francisco, CA
* Over-The-Counter Drug Monograph System — Past, Present and Future; Public Hearing; 25-26 Mar 2014; Silver Spring, MD
* International Medical Device Regulators Forum (IMDRF) – Stakeholders Meeting; 26 Mar 2014; San Francisco, CA
Rescheduled Public Meeting on Fibromyalgia Patient-Focused Drug Development; 26 Mar 2014; Silver Spring, MD
Molecular and Clinical Genetics Panel of the Medical Devices Advisory Committee Meeting; 26-27 Mar 2014;  Gaithersburg, MD