Is Fda’s Breakthrough Therapy Designation A Game-Changing Trend For Patients And Payers?

Developing standards for breakthrough therapy designation in oncology.

In July 2012, Congress passed the Food and Drug Administration Safety and Innovation Act (FDASIA). The Advancing Breakthrough Therapies for Patients Act was incorporated into a Title of FDASIA to expedite clinical development of new, potential "breakthrough" drugs or treatments that show dramatic responses in early-phase studies. Using this regulatory pathway, once a promising new drug candidat...

Expediting drug development--the FDA's new "breakthrough therapy" designation.

The FDA's new "breakthrough therapy" designation for investigational drugs adds to the agency's portfolio of expedited programs for serious conditions. The designation requires preliminary clinical evidence demonstrating substantial improvement over existing therapies.

Accelerated approval and breakthrough therapy designation: oncology drug development on speed?

Recent advances in biotechnology have led to discoveries resulting in major improvements in the therapy of refractory malignancies, although most advanced cancers remain incurable. Thus, there is global consensus around the need to streamline the drug approval process for effective agents. Accelerated Approval and Breakthrough Therapy Designation hold the promise of making new treatments availa...

Heavy Metals Levels in Plastics Housing of Televisions: Is there a changing trend across three decades (1980-2000)?

Background: This study investigated the concentration of some heavy metals in plastic housing of televisions produced over three decade (1980-2000) with the aim of providing information and comparing the trend in the concentration of these metals. Methods: The heavy metal concentrations were determined by atomic absorption spectroscopy after acid digestion using a 1:1 mixture of sulphuric an...

Hypertension self-management: a home run for patients and payers.