Open Access. Powered by Scholars. Published by Universities.®
- Keyword
- Publication
- Publication Type
Articles 1 - 4 of 4
Full-Text Articles in Medicine and Health Sciences
The Biologics Price Competition And Innovation Act: Is A Generic Market For Biologics Attainable?, Kasey E. Koballa
The Biologics Price Competition And Innovation Act: Is A Generic Market For Biologics Attainable?, Kasey E. Koballa
William & Mary Business Law Review
The Biologics Price Competition and Innovation Act of 2009 (BPCIA) provides an abbreviated approval pathway for biological therapeutic products shown to be biosimilar to an FDA-approved biological reference product. The BPCIA purported to reduce the price of biologics while promoting innovation. In two recent cases, the Federal Circuit interpreted a key provision of the BPCIA requiring an applicant to provide the reference product sponsor with notice 180 days before marketing the product. The Federal Circuit’s interpretation extends the exclusivity period already provided for the reference product sponsor, deterring innovation and price reduction. Thus, the Supreme Court granted certiorari in one …
Establishing A Floor: Minimum Remediation Requirements For Meth Labs, Chelsea Bobo
Establishing A Floor: Minimum Remediation Requirements For Meth Labs, Chelsea Bobo
William & Mary Environmental Law and Policy Review
No abstract provided.
Should Liability Play A Role In The Social Control Of Biobanks?, Larry I. Palmer
Should Liability Play A Role In The Social Control Of Biobanks?, Larry I. Palmer
Faculty Publications
No abstract provided.
Preserving A Precious Resource: Rationalizing The Use Of Antibiotics, Eric Kades
Preserving A Precious Resource: Rationalizing The Use Of Antibiotics, Eric Kades
Faculty Publications
No abstract provided.