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Jun 01 2015

New FDA Guidances for May 2015

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 May, are posted. In addition, upcoming advisory committee meetings and other public meetings hosted by FDA are listed below with links to more information.

Also, as we strive to keep you updated on the latest FDA guidances, please note that FDA has officially withdrawn 47 draft guidances.  All guidances were published prior to 31 December 2013 but were never finalized.  The full list of withdrawn guidances, published in the Federal Register on 06 May 2015, can be found here:  http://www.gpo.gov/fdsys/pkg/FR-2015-05-06/html/2015-10477.htm.

Special Interest Guidances/Information Date Posted
Established Conditions: Reportable CMC Changes for Approved Drug and Biologic Products Guidance for Industry – Draft Guidance 29 May 2015
M7 Assessment and Control of DNA Reactive (Mutagenic) Impurities in Pharmaceuticals to Limit Potential Carcinogenic Risk – Final Guidance 27 May 2015
Class II Special Controls Guideline: Multiplex Nucleic Acid Assay for Identification of Microorganisms and Resistance Markers from Positive Blood Cultures – Final Guidance 27 May 2015
ANDA Submissions — Refuse-to-Receive Standards – Final Guidance 26 May 2015
Adaptive Designs for Medical Device Clinical Studies – Draft Guidance 18 May 2015
Patient Preference Information – Submission, Review in PMAs, HDE Applications, and De Novo Requests, and Inclusion in Device Labeling– Draft Guidance 18 May 2015
Investigational New Drug Applications Prepared and Submitted by Sponsor-Investigators– Draft Guidance 14 May 2015
Investigational Enzyme Replacement Therapy Products: Nonclinical Assessment – Draft Guidance 12 May 2015
Biosimilars: Additional Questions and Answers Regarding Implementation of the Biologics Price Competition and Innovation Act of 2009 – Draft Guidance 12 May 2015
Revised Recommendations for Reducing the Risk of Human Immunodeficiency Virus Transmission by Blood and Blood Products – Draft Guidance 12 May 2015
Leveraging Existing Clinical Data for Extrapolation to Pediatric Uses of Medical Devices – Draft Guidance 06 May 2015
Providing Regulatory Submissions in Electronic Format – Certain Human Pharmaceutical Product Applications and Related Submissions Using the eCTD Specifications – Revision 3; Draft Guidance 05 May 2015
Waiver of In Vivo Bioavailability and Bioequivalence Studies for Immediate-Release Solid Oral Dosage Forms Based on a Biopharmaceutics Classification System – Revision 1, Draft Guidance 05 May 2015
Acceptance of Medical Device Clinical Data from Studies Conducted Outside the United States – Draft Guidance 22 Apr 2015
Upcoming Meetings (* = New)
Transmissible Spongiform Encephalopathies Advisory Committee Meeting; 01 June 2015; Silver Spring, MD
* Joint Meeting of the Bone, Reproductive and Urologic Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee Meeting; 04 June 2015; Silver Spring, MD
* Risk Communication Advisory Committee Meeting; 08-09 June 2015; Silver Spring, MD
Endocrinologic and Metabolic Drugs Advisory Committee Meeting; 09 June 2015; Gaithersburg, MD
Endocrinologic and Metabolic Drugs Advisory Committee Meeting; 10 June 2015; Gaithersburg, MD
* June 11, 2015: Pulmonary-Allergy Drugs Advisory Committee Meeting; 11 June 2015; Gaithersburg, MD

* new entry

Last updated: 01 June 2015