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.
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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.
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FDA Inspection Checklist: Dos and Don’ts

Just got a call from the FDA?  Don't panic! Here's an FDA inspection checklist to help you prepare and make the inspection a success. 

Halloran regularly has conversations with potential clients that begin like this: We just got the call from the FDA, and they’re coming for an inspection.

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