The FDA’s Rare Disease Framework Initiative brings risk-based CMC review and pre-approval inspections into scope for sponsors, CDMOs, and quality teams.
|Podcasts|September 8, 2011
PDA-FDA 2011 to Focus on Compliance
Meeting Co-Chair Susan Schniepp provides insight into this year's regulatory conference.
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A 2011 PDA-FDA Joing Regulatory ConferencePreview
Co-Chair of the 2011 PDA-FDA Joint Regulatory Conference Susan Schniepp talks with Angie Drakulich, senior managing editor of Pharmaceutical Technology, about what to expect at this year's meeting. Schniepp is vice-president of quality for OSO Biopharmaceuticals and a member of PharmTech's editorial advisory board. FDA's enforcement strategy, compliance, industry best practices and more are addressed.
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