This article will share recent analysis of price increases within the healthcare sector in an effort to understand the growth of healthcare expenditures and pharmaceutical prices over time.
The draft guidance calls for sponsors of new drug and biologics license applications to apply population PK analysis, which is frequently used to guide drug development on therapeutic individualization.
The new EU draft guidance Guideline on the quality requirements for drug-device combinations and U.S. draft guidance Principles of Premarket Pathways for Combination Products are the latest attempts by each body to adequately regulate combination products. In this two-part series, we examine the two guidances in detail. Part 1 covers the U.S. regulatory guidance.
This article explores some of the typical issues that may be encountered during recovery studies and show how the use of statistical tools for assessing the recovery data can provide greater insight into the results and enable data-driven decisions concerning recovery studies. To do so, we will look at three case studies.
The majority of biologic products today are launched as some form of combination product, stringently regulated by the FDA through 21 CFR Part 4. This article looks at important manufacturing, packaging, and other factors that developers of combination products must consider and why they need to be considered early in the device development program.
Understanding how to be appropriately staffed and being prepared to explain any perception of inequity could mean the difference between success and failure of appropriate data integrity in both regulatory compliance and product support.
This is Part 1 of a two-part article discussing important areas to consider when developing devices for combination products — and why they need to be addressed early in development.
Developing a continuous manufacturing (CM) process for a new drug or implementing CM for an existing batch process demands significant time, effort, and money. Adapting any manufacturing process to CM requires in-depth chemical and mechanical engineering understanding as well as the right technologies.
In the United States, a national debate on drug pricing is taking place, with questions being raised about why U.S. patients pay some of the highest fees in the world to access prescription medicines. One drug class in the spotlight more than others is the insulins, as U.S. politicians put their pricing and the manufacturers that market them under scrutiny.
Why does “Quality” seem like such a slippery, elusive term? The answer is easy: It’s because the people who claim to know it really don’t. And everyone else is exhibiting a form of the psychological bias known as the bandwagon effect, in which they go along with the rhetoric because everyone else is.