GLOBAL COMPLIANCE SEMINAR

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3500A

FDA Electronic Medical Device Reporting and eMDR Files

The United States Food and Drug Administration Electronic Medical Device Report (eMDR) Files Health Level Seven (HL7) Individual Case Safety Reporting (ICSR) Files The FDA/CDRH staff has created a packet of files to assist in implementing software for generating the

Apr

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FDA Guidance on Expansion of the Abbreviated 510k Program
FDA Issued the Draft Guidance on the Expansion of the Abbreviated 510(k) Program Today, the United States Food and Drug Administration (FDA) has issued the (more…)
Completeness Assessments for Type II API DMFs Under GDUFA
FDA Guidance for the Industry Completeness Assessments for Type II API DMFs Under GDUFA By Global Compliance Seminar (LinkedIn; Twitter) This guidance is intended for holders of Type (more…)
Use of ISO 10993-1 for Medical Device Risk Management Process
FDA Guidance for Industry By Global Compliance Seminar (LinkedIn; Twitter) Use of International Standard ISO 10993-1, “Biological evaluation of medical devices – Part 1: Evaluation and testing within (more…)
FDA Data Integrity and Compliance with CGMP
FDA Guidance for the Industry By Global Compliance Seminar (LinkedIn; Twitter) Data Integrity and Compliance With CGMP The purpose of this guidance is to clarify the role of (more…)
ANDA Submissions-Content and Format
Guidance for Industry By Global Compliance Seminar (LinkedIn; Twitter) ANDA Submissions-Content and Format of Abbreviated New Drug Applications June 2014 Generics This guidance is intended to assist applicants (more…)