Coordinating new drug application (NDA) and patent portfolio strategy -- Preclinical R&D -- Preclinical patent considerations -- Clinical trials and regulatory considerations -- Clinical trial-patent considerations -- Trademark (TM) and nonproprietary name considerations -- Investigational new drug (IND) and new drug applications (NDA) -- Regulatory exclusivity -- Overview of the NDA review process -- Orange book listable patents -- Postmarketing regulatory requirements and life cycle management -- Patent prosecution -- Acquiring and in-licensing pharmaceutical products : due diligence issues -- Pre-litigation investigations and due diligence -- Market entry business considerations for generic companies -- Intellectual property considerations for generic product opportunities -- Preparation of noninfringement/invalidity legal opinions -- ANDA preparation (with an eye toward approval and litigation) and the FDA review -- Obtaining ANDA approval and right to market -- Providing notice to the NDA holder -- Evaluating scenarios for launch, including marketing, and manufacturing developments -- Citizen petitions -- Expedited regulatory pathways -- Biologic drugs and the Biologics Price Competition and Innovation Act -- Pharmaceutical regulation and approval in foreign countries.
This resource is supported by the Institute of Museum and Library Services under the provisions of the Library Services and Technology Act as administered by State Library of Iowa.