Drug and Device Digest

READS

Editorial: When Drugs Don’t make it to market. We need to know why and regulators should tell us.

Mintzes B., British Medical Journal.

2015; 350  doi: http://dx.doi.org/10.1136/bmj.h2852 (Published 09 June 2015)

Analysis: FDA does not post rejections (Complete Response Letters are confidential). Brief External communication only if company is publicly traded in the US.  No public knowledge of the totality of evidence and FDA analysis of Risks to outweigh Benefits. Sharing of learnings, while protecting competitive/confidential information, is absent. FDA should take a cue from EMA who posts non-approval assessments.

New Guidances:

• 6/16/15:  Naming of Drug Products Containing Salt Drug Substances
• 6/17/15:  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 – Guidance for Industry and Food and Drug Administration Staff
•  6/18/15:  CVM GFI #187 Regulation of Genetically Engineered Animals Containing Heritable Recombinant DNA Constructs
•  6/18/15:  Factors to Consider When Making Benefit-Risk Determinations for Medical Device Investigational Device Exemptions – Draft Guidance for Investigational Device Exemption Sponsors, Sponsor-Investigators, and Food and Drug Administration Staff
•  6/18/15:  Size, Shape, and Other Physical Attributes of Generic Tablets and Capsules

http://www.fda.gov/RegulatoryInformation/Guidances/default.htm?source=govdelivery&utm_medium=email&utm_source=govdelivery

Framework and structured approach to facilitate new device clinical investigation by expediting IDE decision making –  CONTEXT, RISK ASSESSMENT, BENEFIT ASSESSMENT, PATIENT PREFERENCE, UNCERTAINTY