News | December 04, 2007

Free White Paper Discusses Challenges of New FDA Rules for Combo Product Makers

December 4, 2007 - A new, free white paper, addressing the challenges of new FDA regulations awaiting combination products manufacturers, is now available for download from Microtest, a testing services and contract manufacturing for the medical device, pharmaceutical, biotechnology industries.

While combination products are experiencing dramatic growth, the convergence of drug/biologics and devices brings a host of regulatory challenges. Manufacturers must ensure their products meet cGMP practices as well as pass muster with the FDA, ISO and USP.

Navigant consulting, estimating the combination products market at $5.9 billion in 2004, predicts a nearly $9.5 billion market in 2009. In 2005, the FDA received 275 combo product submissions, and an estimated 30 percent of new products under development today are combo products.

The paper’s contents include defining the convergence, FDA responsibility, QC drug release criteria, biologics, new developments in FDA thinking and future considerations.

For more information: www.microtestlabs.com/combinationpaper

Related Content

Artificial Intelligence Performs As Well As Experienced Radiologists in Detecting Prostate Cancer
News | Artificial Intelligence | April 18, 2019
University of California Los Angeles (UCLA) researchers have developed a new artificial intelligence (AI) system to...
A smart algorithm has been trained on a neural network to recognize the appearance of breast cancer in MR images

A smart algorithm has been trained on a neural network to recognize the appearance of breast cancer in MR images. The algorithm, described at the SBI/ACR Breast Imaging Symposium, used “Deep Learning,“ a form of machine learning, which is a type of artificial intelligence. Graphic courtesy of Sarah Eskreis-Winkler, M.D.

Feature | Artificial Intelligence | April 12, 2019 | By Greg Freiherr
The use of smart algorithms has the potential to make healthcare more efficient.
Videos | RSNA | April 03, 2019
ITN Editor Dave Fornell takes a tour of some of the most interesting new medical imaging technologies displa
NIH Study of Brain Energy Patterns Provides New Insights into Alcohol Effects

NIH scientists present a new method for combining measures of brain activity (left) and glucose consumption (right) to study regional specialization and to better understand the effects of alcohol on the human brain. Image courtesy of Ehsan Shokri-Kojori, Ph.D., of NIAAA.

News | Neuro Imaging | March 22, 2019
March 22, 2019 — Assessing the patterns of energy use and neuronal activity simultaneously in the human brain improve
Book Chapter Reports on Fonar Upright MRI for Hydrocephalus Imaging

Rotary misalignment of atlas (C1) and axis (C2). Image courtesy of Scott Rosa, DC, BCAO.

News | Magnetic Resonance Imaging (MRI) | March 20, 2019
Fonar Corp. reported publication of a chapter where the physician-author-researchers utilized the Fonar Upright Multi-...
Non-Contrast MRI Effective in Monitoring MS Patients
News | Neuro Imaging | March 18, 2019
Brain magnetic resonance imaging (MRI) without contrast agent is just as effective as the contrast-enhanced approach...
New MRI Sensor Can Image Activity Deep Within the Brain
News | Magnetic Resonance Imaging (MRI) | March 15, 2019
Calcium is a critical signaling molecule for most cells, and it is especially important in neurons. Imaging calcium in...