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All "Fda" articles

FDA
• September 28, 2023

5 things we learned at the PDA/FDA Joint Regulatory Conference 2023
FDA
• August 09, 2023

PMA submissions: 4 PMA application methods for medical devices
FDA
• July 20, 2023

Guide to 21 CFR Part 11 compliance [free checklist]
FDA
• July 19, 2023

PMA meaning: understanding FDA pre-market approval
FDA
• July 03, 2023

21 CFR Part 820: the complete overview
FDA
• January 25, 2023

The 3 FDA medical device classes: differences and examples explained
FDA
• May 27, 2022

5 ways to make the FDA audit process easier for your life sciences company

Benjamin Franklin once said that two things in life are certain—death and taxes—and if you’re running a life sciences company, add going through the ...
FDA
• January 24, 2022

The FDA's approach to digital health technology (DHT) is changing. That's a big deal.

In December 2021, the FDA revealed its draft guidance on "Digital Health Technologies for Remote Data Acquisition in Clinical Investigations".
Medical Devices
• July 27, 2021

How Long Does the FDA Medical Device Approval Process Take? [Timeline]

How long before your medical device startup runs out of money? That depends on how long it takes before you start generating revenue. And generating ...
FDA
• May 06, 2021

What is the FDA 21 CFR? Requirements Overview

What is the best way to ensure that your medical device complies with all applicable laws and regulations? Title 21 of the Code of Federal ...
FDA
• December 10, 2020

5 FDA Audit Preparation Tips for Life Science Startups

Are you preparing for an FDA audit? If so, there's a lot that can go wrong if your organization fails to take the time to adequately prepare. ...
FDA
• October 15, 2020

FDA to Issue New Guidance on QMS Validation: 4 Major Changes

Are you having difficulty validating a quality management system (QMS)? As you know, validation provides a level of confidence in the software's ...
Medical Devices
• September 29, 2020

5 FDA Pre-Submission Tips for Medical Device Manufacturers

You've just designed the greatest medical device of all-time. Now what? If you've developed a medical device similar to one that's already available ...
FDA
• September 01, 2020

What Are The Top FDA Software Validation Requirements? [Review]

Learn about the FDA and its current guidance on General Principles of Software Validation and how it has changed since its initial release date in ...
Medical Devices
• April 18, 2019

4 Reasons Overhauling FDA 510(k) is a Great Move

Recent high-profile failures of medical devices have caused harm and injury to patients while damaging the FDA and medical device industry's ...
Pharmacy
• March 31, 2018

FDA Rolls Out New Drug Research and Development Pilot Program

It’s no secret that some of the biggest challenges faced by the healthcare industry revolve around data and transparency. Improving the patient ...
FDA
• September 28, 2016

Pharmaceutical Testing, Training, Documentation Updates from the FDA

It's been a busy few weeks as the FDA continues to approve and release new drugs and various pharmaceuticals products. In recent weeks, the ...
Medical Devices
• September 07, 2016

FDA Provides Wellness Device Testing Guidelines. What's Your Next Move?

Last month, the US Food and Drug Administration (FDA) released a document that provides guidelines and compliance information for companies that ...