Webinar: Orange Book listing sheets under the microscope
Key Considerations for Reshoring U.S. Drug Manufacturing
Drug Pricing Initiatives During the Trump Presidency
Podcast: IP Life Sciences Landscape: Aiding Orange and Purple Book Patent Owners in Developing PTAB Survival Skills
Patent law in Europe: What pharmaceutical companies need to know
EU excessive pricing laws
Polsinelli Podcast - Generic Drugs to Market - What's the Climate in 2014?
On March 27, 2020, President Trump signed the Coronavirus Aid, Relief, and Economic Security Act, or CARES Act, into law in response to the COVID-19 pandemic. Among other healthcare-related provisions, the CARES Act addresses...more
As a follow up to our recent blog post, FDA User Fees: Highlights from FDARA & Our Forecast for the Next Round, President Trump signed the bipartisan over-the-counter (OTC) monograph reform bill into law on March 27, 2020....more
Wednesday, FDA released a letter stating how the agency intends to implement the scope of orphan drug exclusivity awarded to Eagle Pharmaceuticals’ Bendeka (bendamustine HCl) by the D.C. Circuit Court in Eagle...more
Pharmaceutical industry stakeholders know that drug prices, market competition, supply chain challenges, and shortages of critical drug products have been top of mind for policymakers in recent years. Among others tackling...more
The US Food and Drug Administration’s (FDA’s) 2017 regulatory agenda was marked by inactivity in the months following the presidential inauguration. Since FDA Commissioner Scott Gottlieb’s Senate confirmation in May 2017, the...more
As is the tradition here at Health Law & Policy Matters, towards the end of the year we take stock of what transpired in our respective industries and highlight important legal, regulatory, and business developments. For...more
The Food and Drug Administration (FDA) has announced implementation of a new “concept of operations” that seeks to improve FDA’s oversight over pharmaceutical manufacturers. The concept of operations complements FDA’s program...more
On August 18, 2017, President Trump signed into law the FDA Reauthorization Act (FDARA). FDARA reauthorizes user fees paid to FDA to support regulatory review of innovator drugs and biologics, medical devices, generic drugs,...more
Following nearly two years of negotiations and hearings examining the Generic Drug User Fee Amendments (GDUFA) and the Biosimilar User Fee Act (BsUFA), the Prescription Drug User Fee Act (PDUFA) and the Medical Device User...more