Law.com Subscribers SAVE 30%
Call 855-808-4530 or email [email protected] to receive your discount on a new subscription.
The Medicare Modernization Act of 2003:The Effect on Entry of Generic Drugs into the Marketplace
The Hatch-Waxman Act, enacted in 1984, first permitted the marketing of generic pharmaceuticals based on a showing of bioequivalence, not safety and efficacy, through the use of an Abbreviated New Drug Application (“ANDA”). By significantly lowering the barrier to entry for generics, this change provided the impetus for rapid growth of the generic pharmaceutical industry in the United States. In exchange for this barrier lowering, Congress provided the holder of the previously approved new drug application (“NDA”) with patent term extensions based on FDA regulatory delay.
Under the Hatch-Waxman Act, the NDA holder must submit information to the FDA regarding patents that cover the drug product or a method of using it. The FDA then lists these patents in the “Orange Book.” A company seeking FDA approval to market a generic version of the product by submitting an ANDA must make at least one of four types of certifications to the FDA regarding patents. One type is a “Paragraph IV certification,” which certifies that a patent listed in the Orange Book for a drug product is invalid or will not be infringed by the ANDA product.
This premium content is locked for Entertainment Law & Finance subscribers only
ENJOY UNLIMITED ACCESS TO THE SINGLE SOURCE OF OBJECTIVE LEGAL ANALYSIS, PRACTICAL INSIGHTS, AND NEWS IN ENTERTAINMENT LAW.
- Stay current on the latest information, rulings, regulations, and trends
- Includes practical, must-have information on copyrights, royalties, AI, and more
- Tap into expert guidance from top entertainment lawyers and experts
Already a have an account? Sign In Now Log In Now
For enterprise-wide or corporate acess, please contact Customer Service at [email protected] or 877-256-2473
The DOJ's Corporate Enforcement Policy: One Year Later
The DOJ's Criminal Division issued three declinations since the issuance of the revised CEP a year ago. Review of these cases gives insight into DOJ's implementation of the new policy in practice.
Use of Deferred Prosecution Agreements In White Collar Investigations
This article discusses the practical and policy reasons for the use of DPAs and NPAs in white-collar criminal investigations, and considers the NDAA's new reporting provision and its relationship with other efforts to enhance transparency in DOJ decision-making.
The DOJ's New Parameters for Evaluating Corporate Compliance Programs
The parameters set forth in the DOJ's memorandum have implications not only for the government's evaluation of compliance programs in the context of criminal charging decisions, but also for how defense counsel structure their conference-room advocacy seeking declinations or lesser sanctions in both criminal and civil investigations.
How AI Has Affected PR
When we consider how the use of AI affects legal PR and communications, we have to look at it as an industrywide global phenomenon. A recent online conference provided an overview of the latest AI trends in public relations, and specifically, the impact of AI on communications. Here are some of the key points and takeaways from several of the speakers, who provided current best practices, tips, concerns and case studies.