martes, 8 de diciembre de 2015

CDER SBIA Update: New Guidances and Notices from FDA

FDA/CDER's Small Business and Industry Assistance (CDER SBIA)

New Guidances and Notices from FDA
1. Guidance for Industry and Review Staff: Best Practices for Communication Between IND Sponsors and FDA During Drug Development
The purpose of this guidance is to describe best practices and procedures for timely, transparent, and effective communications between investigational new drug application (IND) sponsors and FDA at critical junctures in drug development, which may facilitate earlier availability of safe and effective drugs to the American public.
2. Guidance for Industry: Formal Meetings Between the Food and Drug Administration and Biosimilar Biological Product Sponsors or Applicants
This guidance provides recommendations to industry on formal meetings between FDA and sponsors or applicants relating to the development and review of biosimilar biological products regulated by the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER). The guidance assists sponsors and applicants in generating and submitting meeting requests and the associated meeting packages to FDA for biosimilar biological products. This guidance finalizes the draft guidance issued on April 1, 2013.
3. Revised Draft Guidance for Industry: Certification Process for Designated Medical Gases
The original version of this draft guidance was published by FDA on December 18, 2012. The revised draft guidance, like the original version, describes the certification process created by the Food and Drug Administration Safety and Innovation Act (FDASIA) for certain medical gases and explains how FDA plans to implement that process. In response to comments received, we have revised the draft guidance and are reissuing it in draft form to enable the public to review and comment before it is finalized.
4. Sunscreen Innovation Act: Regulatory Policy Information and New Guidance Documents –
FDA has released four new guidance documents relating to the Sunscreen Innovation Act:

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