Tag Archive: CAPA

Jan 30

Combination Products: What’s New?

A monoclonal antibody combined with a therapeutic drug. An EpiPen®. A drug packaged with its delivery device. All of these are examples of combination products. A combination product, according to the FDA, is “a product composed of any combination of a drug and a device; a biological product and a device; a drug and a …

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Jul 27

FDASIA, Part 2: Pediatric Drugs and Devices and Medical Device Regulatory Improvements

On 09 July 2012, the Food and Drug Administration Safety and Innovation Act (FDASIA, otherwise known as PDUFA V) was signed into law.  In a 4-part weekly series, we are covering the major changes in FDASIA as follows: Part 1: The “UFAs”: PDUFA, MDUFA, GDUFA, and BsUFA Part 2: Pediatric Drugs and Devices and Medical …

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Jun 08

Warning: Your “Check CAPA” Light is On

The FDA has reported that over 50% of the top 10 Form FDA 483 observations and warning letters are related to one process: CAPA, otherwise known as Corrective and Preventive Actions.  How to respond to warning letters has been covered previously in this forum, but today I want to focus on one specific aspect of …

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Jun 08

Warning: Your “Check CAPA" Light is On

The FDA has reported that over 50% of the top 10 Form FDA 483 observations and warning letters are related to one process: CAPA, otherwise known as Corrective and Preventive Actions.  How to respond to warning letters has been covered previously in this forum, but today I want to focus on one specific aspect of …

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May 26

What everyone should know about responding to Warning Letters.

It takes less time to do something right than it takes to explain why you did it wrong. -Lee’s Law Interestingly enough, many people do not take advantage of the Warning Letters posted on the FDA website.  Personally, I always prefer to learn from the mistakes of others, rather than flounder through the same mistakes …

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