FDA Extends Enforcement Deadline for Drug Supply Chain Security Act (DSCSA) Requirements | by: Sumeet Singh, Founder & Chairman | Article Posted: September 6, 2023 | Introduction The U.S. Food and Drug Administration (FDA) recently announced an extension on the...
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.
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.
New York Opioid Tax & Minnesota Regulatory Fee Changes As the changes to state laws per DSCSA continues to sweep the country, the Opioid...
DEA Insights from the 2018 DEA Diversion Conference The DEA hosted a conference in San Antonio, TX that addressed multiple aspects of how those that...
