New pharmaceutical drugs hit the market every day. As the ailments that hinder people continue to evolve, there will be more drugs needing to be tested and investigated before going to market. With every new drug comes adverse side effects. Without proper testing, people could be seriously harmed or die from ingesting a new medication.
FDA Involvement with Pharma
The FDA is in charge of enforcing federal regulations involving all pharmaceuticals, including drugs, biologics, medical devices, and others. During the clinical development of a product, the FDA focuses on ensuring a safety profile is developed. As such, a drug safety protocol requiring the submission of reports for any adverse, serious, or unexpected events is required. This is necessary before and after the drug and consequent marketing takes place.
What is Pharmacovigilance?
Pharmacovigilance came about due to these stringent regulations placed upon companies from the FDA. Pharmacovigilance (PV) is the study of these biologic and medication adverse effects. Patient and healthcare provider information used in pharmacovigilance is:
This process ensures a drug is safe enough for the public. Pharmacovigilance requires expertise in the areas of:
Without a solid pharmacovigilance plan, your new drug may never reach the market. It's absolutely vital to consider pharmacovigilance before human testing, throughout product development and post-marketing of the product. How PV Makes Medicines Safer.
There are many steps in pharmacovigilance to make medicines safe including:
Screening of literature
The FDA's robust set of regulations includes a signal detection program. Pharmacovigilance makes sure companies understand these regulations and abides by them. A proper drug safety protocol allows for quick identification of any risks and further, management of the identified problems. This means patients have access to only the drugs with the highest standard of safety.
Your Pharmacovigilance Resource
Companies in the drug safety industry must be up to date on numerous federal regulations that are ever-changing. If you're a pharmaceutical company with drug safety needs, look no further. At Unicon Pharma, we offer the premier pharmacovigilance services to get your drug off to market safely. Get in touch to learn more today.