2006 PDA Regulatory Comments

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Parenteral Drug Association Connecting People, Science and Regulation ^®

PDA Comments on Virus Safety Evaluation of Biotechnological Investigational Medicinal Products Guidance2

PDA Comments on Virus Safety Evaluation of Biotechnological Investigational Medicinal Products Guidance1

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PDA Comments on GMP Annex 1-3

PDA Comments on GMP Annex 1-3

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PDA Comments on Virus Safety Evaluation of Biotechnological Investigational Medicinal Products Guidance1

Cover Letter to the EMEA, Dec. 28, 2006

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PDA Comments on GMP Annex 1-2

PDA Comments on EMEA’s Annex 1

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PDA Comments on GMP Annex 1-1

Cover Letter to the EMEA, April 24, 2006

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PDA Comments on Draft FDA Guidance for Industry - Phase I GMPs

Excel Spreadsheet

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PDA Comments on Biological Starting Materials Guidance2

Submission Comments on Biological Starting Materials Guidance

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Draft Guidance for Industry INDs - Approaches to Complying with CGMP During Phase I Docket No 2005D-0286

Draft Guidance for Industry: INDs — Approaches to Complying with CGMP During Phase I, Docket No. 2005D-0286

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Direct Final and Proposed Rules Current Good Manufacturing Practice Regulation and Investigational New Drugs

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2006 FDA Cover Letter Direct and Final Rule

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PDA Comments on Biological Starting Materials Guidance1

Cover Letter to the U.S. FDA, Dec. 21, 2006

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Annex 1 Comment Submission Document to the EMEA

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