Jul 02 2015

New FDA Guidances for June 2015

By Brant Hamel, Ph.D. and Sheila Plant, Ph.D., R.A.C., Regulatory Scientists at Cato Research
FDA draft and final guidances, released from CDER, CBER, and CDRH in June 2015, are posted.  In addition, a single upcoming advisory committee meeting to be held in July is also listed below with a link to more information.

Special Interest Guidances/Information Date Posted
Premarket Notification Requirements Concerning Gowns Intended for Use in Health Care Settings – Draft Guidance 30 Jun 2015
DSCSA Implementation: Product Tracing Requirements for Dispensers – Final Guidance 30 Jun 2015
Assessment of Radiofrequency-Induced Heating in the Magnetic Resonance (MR) Environment for Multi-Configuration Passive Medical Devices – Draft Guidance 29 Jun 2015
Unique Device Identification: Direct Marking of Devices – Draft Guidance 26 Jun 2015
Allowable Excess Volume and Labeled Vial Fill Size in Injectable Drug and Biological Products– Final Guidance 24 Jun 2015
Size, Shape, and Other Physical Attributes of Generic Tablets and Capsules– Final Guidance 18 Jun 2015
Factors to Consider When Making Benefit-Risk Determinations for Medical Device Investigational Device Exemptions– Draft Guidance 18 Jun 2015
Content and Format for Abbreviated 510(k)s for Early Growth Response 1 (EGR1) Gene Fluorescence In-Situ Hybridization (FISH) Test System for Specimen Characterization Devices – Final Guidance 17 Jun 2015
Naming of Drug Products Containing Salt Drug Substances – Final Guidance 16 Jun 2015
Assessment of Male- Mediated Developmental Risk for Pharmaceuticals Guidance for Industry – Draft Guidance 11 Jun 2015
Pregnancy, Lactation, and Reproductive Potential: Labeling for Human Prescription Drug and Biological Products — Content and Format Guidance for Industry (Small Entity Compliance Guide) – Final Guidance 10 Jun 2015
Duchenne Muscular Dystrophy and Related Dystrophinopathies: Developing Drugs for Treatment Guidance for Industry – Draft Guidance 9 Jun 2015
Considerations for the Design of Early-Phase Clinical Trials of Cellular and Gene Therapy Products – Final Guidance 9 Jun 2015
Upcoming Meetings (* = New)
* Oncologic Drugs Advisory Committee Meeting, 09 July 2015; Silver Spring, MD

* new entry
Last updated: 01 July 2015