DIA's Content Currents | APRIL 12, 2013

DIA's Content Currents provides you with new and important global regulatory developments and their impact on pharmaceutical, biotechnology, and medical product development.




EDITION PUBLISHED: APRIL 12, 2013

SECTION 1: FDA GUIDANCES
SECTION 2: FDA NOTES & RELATED NEWS
SECTION 3: AGENCY AND ADVISORY COMMITTEE MEETINGS
SECTION 4: OTHER REGULATORY AUTHORITIES & ORGANIZATIONS
SECTION 5: COMPLIANCE & LEGAL NEWS


SECTION 1: FDA GUIDANCES

April 12, FDA announced the availability of a draft guidance document entitled, “M7 Assessment and Control of DNA Reactive (Mutagenic) Impurities in Pharmaceuticals to Limit Potential Carcinogenic Risk.” This draft guidance is intended to provide recommendations and a framework that can be applied for the identification, categorization, qualification, and control of mutagenic impurities. [Draft Guidance] (FDA.gov) This document reached step 2 of the ICH process in February 2013, meaning that it was sent simultaneously to each of the ICH regions for internal and external consultation according to their regional procedures.

April 11, FDA announced the availability of a final guidance document entitled, “Medical Device Classification Product Codes.” This guidance is intended to describe how FDA uses product codes to regulate and track medical devices. [FR Notice]

April 10, FDA announced the availability of a final guidance document entitled, “Self-Selection Studies for Nonprescription Drug Products.” This guidance provides recommendations to industry on the study design, methodology and analyses of self-selection studies. Self-selection studies are used by regulators to determine whether a consumer can reasonably be expected to select an OTC product for an appropriate purpose and follow the labeling such that it is used appropriately. [Guidance] (FDA.gov)

April 9, FDA announced the availability of a draft guidance document entitled, “Molecular Diagnostic Instruments with Combined Functions.” This draft guidance advises industry and agency staff members on the type of information that should be included in a submission for molecular diagnostic instruments that have both device and non-device functions. [FR Notice]

Visit DIAHome.org for complete issue


Sign up for DIA's Global SmartBrief eNews for the latest in drug development innovations worldwide.