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FDA Proposed Rules: Pharma Solutions’ Comment Submission

FDA Proposed Rules: Pharma Solutions’ Comment Submission

FDA Proposed Rules: Pharma Solutions' Comment Submission Preemption Section 585(b): The Proposed Rules suggest that Preemption shall go beyond license requirements and cover standards for Standard Operating Procedures, disciplinary process, recordkeeping requirements,...

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Opioid Tax
Minnesota Board of Pharmacy Fee is a Barrier to Entry

Minnesota Board of Pharmacy Fee is a Barrier to Entry

The 2,200% increase for Minnesota fees has created an unprecedented barrier to entry for small wholesalers and start-up manufacturers. Of our clients, 25% have decided to forego licensure in the state– typically smaller wholesalers and virtual manufacturers who have not yet started a business within the state.

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Minnesota Board of Pharmacy Fee is a Barrier to Entry

A Generic Manufacturer’s Current Pressures and Opportunities

Consolidation of purchase power in the past 20 years has dramatically changed the landscape for generic manufacturers; and recent events are making it worse: active prosecution for price-fixing, the FDA recently announcing a wave of unannounced FDA audits, and blame for the Opioid Epidemic. So what is a generic manufacturer to do? There are opportunities still available for a generic manufacturer to increase their top and bottom lines.

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