Combination products

US regulation of combination products.

The successful launch ofa combination product in the United States (US) will depend on how well a company understands applicable US regulations and policies, which differ in important ways from requirements in Europe. This article provides an overview of useful information on the US regulation of these products that can be found on the newly redesigned Food and Drug Administration website.

A Combination of Testability and Decodability by Tensor Products

Ben-Sasson and Sudan (RSA 2006) showed that repeated tensor products of linear codes with a very large distance are locally testable. Due to the requirement of a very large distance the associated tensor products could be applied only over sufficiently large fields. Then Meir (SICOMP 2009) used this result (as a black box) to present a combinatorial construction of locally testable codes that m...

Is Patent “Evergreening” Restricting Access to Medicine/Device Combination Products?

BACKGROUND Not all new drug products are truly new. Some are the result of marginal innovation and incremental patenting of existing products, but in such a way that confers no major therapeutic improvement. This phenomenon, pejoratively known as "evergreening", can allow manufacturers to preserve market exclusivity, but without significantly bettering the standard of care. Other studies specul...

The Value of a Bd Integrated System for Combination Products

The number of biological therapies in development to treat chronic diseases has risen steadily over the years. The fact that many of these therapies are designed for home delivery by patients or caregivers via subcutaneous injection, combined with the increasing complexity of longer acting formulations, larger injection volumes and longer injection durations, has raised the bar for seamless inj...

Guideline on clinical development of fixed combination medicinal products