As advisory committee meetings grow more difficult - and more political - and drug sponsors receive shorter notice to prepare, a “win” from a panel has become increasing difficult. With a huge investment on the line, learn how to put your best foot forward.
Bigger, Tougher, Faster: Preparing for the New FDA When the inspector comes calling ... will you be ready?
Elsevier Business Intelligence announces the publication of a new 16-page special Report: Bigger, Tougher, Faster: Preparing for the New FDA - When the inspector comes calling ... will you be ready? Originally published in "The Silver Sheet"
Health care reform has become law in
the United States. And, putting aside the politics, you know your
business is about to change in many ways. If you’re pursuing, or
considering a merger, acquisition, joint venture, or collaboration
agreement, or concerned with changes in reimbursement—what is covered,
for whom, and for how much...
A
Special Report from “The Silver Sheet” When Is an iPhone a Medical Device? A
special report from “The Silver Sheet” on increasing FDA regulation of consumer
electronics and software used in medical devices and electronic health records.
The combined U.S. market for home healthcare products reached $4.3 billion in 2007 and (despite current economic recession and uncertainty), is expected to expand at a compound annual growth rate of more than 4%, reaching nearly $5.2 billion in 2012. It is one of the largest and most stable in the United States (U.S.) due to the burgeoning aging population and corresponding increase in lifespan, the critical need for cost-effective medical equipment for patients suffering from long-term chronic conditions, and the increasing usage of technology by the baby-boomer population. Read more...
Diabetes affects nearly 24 million people in the U.S. and is the 5th leading cause of death by disease in the U.S. This costs the U.S. healthcare system more than $130 billion per year. To constrain spiraling healthcare costs, the development of more affordable and effective diabetes management (self-testing and treatment) products has become a top priority not only in the U.S., but worldwide. Diabetes management products have become one of the largest medical device and pharmaceutical markets in the U.S., totaling more than $15 billion. As the population of diabetics continues to increase, the market is expected to continue to grow at a double-digit rate over the next five years, reaching nearly $28 billion by 2013. Read on...
Airway management and ventilation products are reportedly on track to become
a $534 million market. Now you can understand it from every angle with this
new report from Medtech Insight, the leading and most trusted provider of
off-the-shelf medical technology market reports available today.
