martes, 17 de octubre de 2017

New Guidances for Industry: Emerging Technology/ Classification of Drugs and Devices/ ANDAs that Refer to Drugs of rDNA Origin/ ICH M4

New Guidances for Industry
1. Advancement of Emerging Technology Applications for Pharmaceutical Innovation and Modernization - Guidance for Industry
This guidance provides recommendations to pharmaceutical companies interested in participating in a program involving the submission of CMC information containing emerging technology to FDA. The program is open to companies that intend to include the technology as part of a regulatory submission including IND, original or supplemental NDA, ANDA or BLA, or application-associated DMF reviewed by CDER, and where that technology meets other criteria described in this guidance. This program does not cover products reviewed by CBER.
2. Classification of Products as Drugs and Devices and Additional Product Classification Issues; Guidance for Industry and FDA Staff
This guidance document provides the Agency’s current thinking on approaches for classifying products as drugs and devices, and on certain additional product classification issues. FDA regularly receives questions from medical product sponsors concerning the classification of their products. We believe that efficient, effective regulation is facilitated by providing guidance on issues frequently raised in relation to Requests for Designation (RFDs) and other classification activities.  In addition, providing as much clarity and predictability as possible with respect to product classifications should enable informed planning for product development. 
3. ANDAs for Certain Highly Purified Synthetic Peptide Drug Products That Refer to Listed Drugs of rDNA Origin; Draft Guidance for Industry
This guidance is intended to assist potential applicants in determining when an application for a synthetic peptide drug product that refers to a previously approved peptide drug product of rDNA should be submitted as an ANDA rather than as an NDA. Specifically, this guidance covers the following five peptide drug products: glucagon, liraglutide,nesiritide, teriparatide, and teduglutide.
4. M4 Organization of the Common Technical Document for the Registration of Pharmaceuticals for Human Use; International Council for Harmonisation; Guidance for Industry
This guidance updates the Quality-related sections of the Granularity Document Annex, Module 2.3 Quality Overall Summary, and Module 3 Quality. It is intended to provide recommendations on the organization of the CTD/eCTD and replaces the August 2001 FDA guidance for industry ‘‘M4: Organization of the CTD’’ and the October 2005 FDA guidance for industry ‘‘Granularity Document Annex to M4: Organization of the CTD.’’

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