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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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State Compliance Requirements
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

Drug Pricing Transparency Fight Rages On

Even as the COVID-19 pandemic disrupts day-to-day life, drug pricing transparency rages on between consumer groups, regulators, and industry. Regulators are now having to resort to assessing significant fines to increase compliance.

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2020 Update: Continuing Pressure on Drug Manufacturers

2020 Update: Continuing Pressure on Drug Manufacturers

With the developments around COVID-19, the drug manufacturers that working on a cure for the virus have been praised as (potential) saviors across the globe. This is a stark change to how they have regarded over the last few years – drug manufacturers have faced significant scrutiny due to a variety of issues including the opioid epidemic, generic price-fixing and price increases.

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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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