Generic Challenge:. Martin a. Voet
Читать онлайн.| Название | Generic Challenge: |
|---|---|
| Автор произведения | Martin a. Voet |
| Жанр | Медицина |
| Серия | |
| Издательство | Медицина |
| Год выпуска | 0 |
| isbn | 9781627346252 |
New Chemical Entity (NCE) Exclusivity
New Use/Condition of Use/Formulation Exclusivity
Qualified Infectious Disease Products (QIDP)
China, Australia, New Zealand and Canada
| Chapter 6 | Generic Drugs: Hatch Waxman Act |
Patents Listed in the Orange Book
Suits Following Patent Certification
Therapeutic Equivalence Rating
Litigation on Scope of Patent Use Codes
180-day Generic Product Exclusivity
Counterclaim to De-list from the Orange Book
Agreements between Innovators and Generics
Settlement Agreements in Europe
Orphan Exclusivity to Block Generic Approval?
Patent Challenges on the Increase
Inter Partes Review in Hatch Waxman Cases
| Chapter 7 | Generics for Biologic Drugs |
Early Approvals of Biologic Generics
Biosimilars and Interchangeables
Exclusivity for Branded Biologics (BLAs)
Patent Dispute Procedures for Biosimilars
Biosimilar Litigation under BPCIA
FDA Guidance on Biosimilar Development
European Regulation of Biosimilars
Biosimilars in India and Canada
| Chapter 8 | Putting it All Together: Product Life-Cycle Management |