FDA reporting tool

Device manufacturers beware!  FDA recently released a reporting tool to supplement their compliance oversight resources.  Through FDA’s website, anyone can complete and submit a form to report allegations of regulatory misconduct.
Read More

Understanding the 4 Types of FDA Inspections

If you are a manufacturer or a processor of FDA-regulated products, sooner or later, you can expect a visit from FDA. The purpose of this visit is to verify compliance with all relevant regulations — most commonly referred to as an “FDA inspection.”  But not all inspections are created equal.
Read More

Pharma And Physicians – The Key To Successful Clinical Trials

Traditionally in the pharmaceutical and biotech industry worlds, a pharma company develops a candidate product and then works with a group of doctors to test that product under careful standards and procedures—very much managed by the pharma company. If the product shows therapeutic value and safety, it becomes available to prescribers to administer to patients.
Read More