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Oct 12 2016

New FDA Guidances for September 2016

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 September 2016, are posted. In addition, upcoming advisory committee meetings to be held in the next month are listed below with links to more information.

 

Special Interest Guidances/Information Date Posted
Q7 Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients – Draft Guidance 30 Sep 2016
Self-Identification of Generic Drug Facilities, Sites, and Organizations – Final Guidance 22 Sep 2016
Reporting of Computational Modeling Studies in Medical Device Submissions – Guidance for Industry and Food and Drug Administration Staff – Final Guidance 21 Sep 2016
Coordinated Development of Antimicrobial Drugs and Antimicrobial Susceptibility Test Devices – Draft Guidance for Industry and Food and Drug Administration Staff 21 Sep 2016
FDA’s Application of Statutory Factors in Determining When a REMS Is Necessary – Draft Guidance 20 Sep 2016
S9 Nonclinical Evaluation for Anticancer Pharmaceuticals–Questions and Answers – Draft Guidance 16 Sep 2016
Recommendations for Microbial Vectors Used for Gene Therapy – Final Guidance 15 Sep 2016
Qualification of Biomarker Total Kidney Volume in Studies for Treatment of Autosomal Dominant Polycystic Kidney Disease Draft Guidance for Industry – Final Guidance 15 Sep 2016
Qualification of Biomarker Plasma Fibrinogen in Studies Examining Exacerbations and/or All-Cause Mortality in Patients With Chronic Obstructive Pulmonary Disease Guidance for Industry – Final Guidance 14 Sep 2016
Use of Nucleic Acid Tests to Reduce the Risk of Transmission of West Nile Virus from Living Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps) – Final Guidance 12 Sep 2016
510(k) Third Party Review Program – Draft Guidance for Industry, Food and Drug Administration Staff, and Third Party Review Organizations – Draft Guidance 12 Sep 2016
S3A Guidance: Note for Guidance on Toxicokinetics: The Assessment of Systemic – Draft Guidance 8 Sep 2016
E17 General Principles for Planning and Design of Multi-Regional Clinical Trials – Draft Guidance     8 Sep 2016
Guidance for the Submission of 510(k)s for Solid State X-ray Imaging Devices – Final Guidance (supersedes guidance dated 06 Aug 1999) 1 Sep 2016
Upcoming Meetings (* = New)
* Meeting of the Antimicrobial Drugs Advisory Committee; 4 November 2016; Silver Spring, MD
 

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Meeting of the Pharmacy Compounding Advisory Committee Advisory Committee Meeting; 3 November 2016; Silver Spring, MD
* November 1-2, 2016: National Center for Toxicological Research Science Advisory Board Meeting; 1-2 November 2016; Little Rock, AR
 

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Allergenic Products Advisory Committee Meeting; 27 October 2016; Silver Spring, MD
 

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Technical Electronic Product Radiation Safety Standards Committee Meeting; 25-26 October 2016; Gaithersburg, MD
Vaccines and Related Biological Products Advisory Committee Meeting; 13 October 2016, Silver Spring, MD
Meeting of the Bone, Reproductive and Urologic Drugs Advisory Committee – 19 October, Silver Spring, MD
Allergenic Products Advisory Committee Meeting; 27 October 2016, Silver Spring, MD
* new entry

Last updated: 12 October 2016