Post-approval activities have gained importance in a number of different ways since the 1970’s. Initially, post-approval studies hadn’t been a serious concern for regulatory agencies and sponsors. Now post-approval research is considered one of the fastest growing areas, with an annual compounded growth rate of 10.4 per cent. In 2014, 13.7 per cent of total R&D expenditures by pharmaceutical and biotechnology firms were spent on conducting post-approval studies. That’s because the FDA now has the power to demand post-approval research from pharmaceutical companies and impose stricter regulations on the drug manufacturing process.
For students interested in the ways post-approval activities have changed drug research and manufacturing, here is an overview.
Post-Approval Research Can Be Required by the FDA
With the rise of HIV and cancer research, the FDA started to grant accelerated approval to certain drugs that could help patients with these diseases. However, the FDA expected pharmaceutical companies to conduct post-approval studies if their drugs were given accelerated approval. The FDA needed this important research to further determine whether a drug was safe, achieved the desired effect, increased survival, and improved a patient’s quality of life.
Graduates of quality assurance courses may be interested to know that congress passed the FDA Administrative Amendment Act (FDAAA), giving the FDA the authority to remove products from market if a pharmaceutical company fails to conduct the requisite post-approval research. As a result, more and more pharmaceutical companies started taking the initiative to start post-approval research before being asked, in order to maintain the safety standards of their products and protect their assets.
Graduates With Quality Assurance Training Know All About Post-Approval Issues
Professionals with quality assurance training know that pharmaceutical firms all have their fair share of issues related to chemistry, manufacturing, control, and regulation during the post-approval phase. For instance, updated technology and analytical measures can cause problems for pharmaceutical companies.
While this might come as a surprise, pharmaceutical companies and sponsors sometimes actually resist technological innovations, possibly due to study coordinators with overly regulatory mindsets. FDA officials suggest that pharmaceutical companies implementing quality-by-design systems should be able to keep up to date with current technology without much FDA interference.
The FDA also provides helpful guidance documents like SUPAC (Scale Up and Post Approval Change) to firms, so that they may better report post-approval changes, such as particle size, and the manner in which particles are blended and mixed.
Post-Approval Research Could Get Better and More Cost-Efficient
Some professionals working in post-approval research have already made recommendations to improve efficiency and cost effectiveness. One way to reduce costs is to stop having patients meet with doctors at research sites, and have nurses visit patients at home instead. Another is to reduce the amount of interaction between patients and doctors, by providing a phone number to a central physician who can answer their questions. These changes could reduce costs, while improving observations at the same time.
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