An investigational device exemption (IDE) allows for investigational devices to be used in clinical studies to collect the proper safety and effectiveness data….
Combination Products
Concepts of Modern Quality systems
A quality system’s main purpose is to consistently produce safe and effective goods while also guaranteeing that these actions are sustainable long term. It should be emphasized that putting in place an effective quality system in a manufacturing company will take a substantial amount of time and effort. By incorporating effective knowledge-building methods into day-to-day operations, a strong quality system will improve…
EMMA International’s Body of Knowledge (BOK)
Do you enjoy all the content from EMMA International? We have good news for you! We are proud to announce that our...
Intolerance vs. Allergy
Millions in the United States alone have an allergic condition, with many of these allergies being related to food....
EU’s Revised Policy for Combination Products
The EU commission released a guidance document this week that explains the commission’s policies for transitioning of...
New FDA Compliance Program for Combination Product Inspections
Last week the FDA released a new compliance program for inspections of CDER-led or CDRH-led combination products to...
Combination Products under the EU MDR
May 2020 deadline for the EU MDR is fast approaching and the industry is scrambling to find the right resources and...
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