For several years, FDA has advanced a policy of increasing diversity in clinical trial populations. During that time, FDA issued broad policy statements, as well as guidance on improved data collection and steps sponsors...more
This is the third article in our five-part series on PTE.
Calculating a drug’s regulatory review period seems like it should be simple. The FDA even states that its regulatory review period determination is...more
5/19/2017
/ Biologics ,
FDA Approval ,
Food and Drug Administration (FDA) ,
Intellectual Property Protection ,
Investigational New Drug Application (IND) ,
Medical Devices ,
Patent Term Extensions ,
Patents ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Prescription Drugs ,
USPTO
This is the second article in our five-part series on PTE.
Everywhere you look, patent term extension (PTE) is described using the “Rule of Ones:” one patent, one product, one PTE. However, the Rule of Ones does not...more
Patent term extension is a valuable tool that drug manufacturers should consider, even when their products are not new entities. Recent decisions from the U.S. Patent and Trademark Office, coupled with various court...more