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,...
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.
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.
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.
How Telemedicine Has Made Generic Drugs Sexy Since 2017, Direct-to-Consumer (DTC) startups (some engaged by Pharma Solutions!) have cropped up to...
The State of Nevada shocked the pharmaceutical supply chain last month by levying an unprecedented $17.4 million in fines due to deficient reporting by drug manufacturers of prescription drugs that are essential for treating diabetes in Nevada.
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.