Content by Tamar June
FDA Proposals Take a Fresh Look at Some Stale Food IssuesComment on FDA's proposed amendments to the Food Safety Modernization Act
Tue, 10/07/2014 - 10:18
The landmark Food Safety Modernization Act (FSMA) just keeps getting more and more important. Earlier this month, the Food and Drug Administration (FDA) unveiled four proposed amendments that will likely make a tough law even tougher.
The FSMA,… The FDA Is Reading Your Facebook Page......and it doesn’t ‘like’ what it sees
Mon, 09/29/2014 - 15:39
In a previous column, Michael Causey looked at the FDA’s relatively ho-hum guidance on social media. Since then, the agency has issued an interesting warning letter to a Utah-based dietary supplement maker for, among other alleged infractions, “… Promises, PromisesCDRH’s strategic priorities promise improved IDE and PMA regulatory climate
Wed, 03/05/2014 - 16:41
The Center for Devices and Radiological Health (CDRH) will focus on encouraging medical device innovation and speeding clinical trials in the coming years, according to its 2014–2015 Strategic Priorities report released Feb. 5, 2014. To help… FDA Warns WebTrader Users: Remove Your Files or Lose ThemOn Feb. 1, 2013, WebTrader inboxes with more than 20 documents will be cleaned. No retrievals.
Mon, 01/21/2013 - 17:05
A Jan. 11, 2013, email sent by Michael Fauntleroy, program manager for the Food and Drug Administration (FDA) Electronic Submissions Gateway (ESG), the agencywide solution for accepting electronic regulatory submissions, warns those using the… FDA Importer Guidance For DevicesGuidance on Good Importer Practices signals 2009 will be a year of a more focused, active agency.
Fri, 04/24/2009 - 10:20
The Food and Drug Administration (FDA) has had many challenges and setbacks in the past few years. From budget cuts, to high-level departures, the agency has also faced fury from lawmakers on Capitol Hill over high-profile device, drug, and food… A Blueprint for Electronic Record RetentionHow to leverage the FDA’s electronic record retention requirements to understand what you need to save and what you need to discard.
Tue, 02/22/2005 - 22:00
Companies struggling to comply with the FDA’s myriad electronic recordkeeping regulations should take a deep breath and follow it up with a long, careful look at the FDA’s actual GxP and 21 CFR Part 11 rules. After a careful reading of the… The Business Case for FDA CFR 21 Part 11 ComplianceComply for the benefits, not just the requirement.
Tue, 01/25/2005 - 22:00
If you are thinking of CFR 21 Part 11 compliance in terms of what the FDA may or may not require, you are missing a huge opportunity to make your business more efficient, nimble and ultimately profitable by improving the quality of your operation… The Business Case for FDA CFR 21 Part 11 ComplianceComply for the benefits, not just the requirement.
Tue, 01/25/2005 - 22:00
If you are thinking of CFR 21 Part 11 compliance in terms of what the FDA may or may not require, you are missing a huge opportunity to make your business more efficient, nimble and ultimately profitable by improving the quality of your operation…
