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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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Drug Takeback
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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