FDA Drug Quality and Security Act Stakeholder Discussion Notes - No Bullwhip

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Updated October 24, 2022

The original link broke.

You can still read about the same topic here:

Drug Quality and Security Act - What You Need to Know - McGuireWoods.com

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FDA Drug Quality and Security Act Stakeholder Discussion Notes - No Bullwhip:

"The FDA held its first public stakeholder call this morning (Dec. 3rd, 2013) to discuss the new Drug Quality and Security Act law. This is the first of a series of public engagements that the FDA will hold as the various provisions of DQSA are phased in starting Jan. 1, 2015 and continuing over the next 10 years.

The call, led by Dr. Ilisa Bernstein and Cara Tenenbaum of the FDA, didn't contain much in the way of hard specifics on rules, regulations and licensure. The FDA is still developing its go-forward plans and communication processes."

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Ten FDA 483s Summarized by FDAzilla Blog

Follow the link below to read FDAzilla Blog's overview of 10 recent 483s.

10 FDA 483 News Stories | FDAzilla Blog:

"Here’s 10 recent stories that have hit our radar related to FDA 483s: . . . "

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SkillsPlus Intl Inc. - The best GMP training, best QSR training, best instructors
SkillsPlus Intl Info Blog

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The Designated Representative Institute

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Entertaining Healthcare Reform Animated Video Primer

This is really great stuff.  I have no patience to digest pages and pages of healthcare reform legislation.  This fun and informative animation makes it all very entertaining and digestible.



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Looking Ahead to Pharma 2010 - Through the IBM innovation lens

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2010 is approaching fast. This is the time of year I start watching out for crystal ball predictions of what's in store for us. For example, check out IBM's vision for 2010, Pharma 2010: The Threshold of Innovation (pdf). 

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FDA 510(k) Free Tips And Pearls Of Wisdom

Updated July 6, 2023

The original links broke.

You might also be interested in:

510(k) Clearances - FDA.gov

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If you're working on a 510(k) medical device submission, you might want to peek at this Medical Device Blog post that's full of great tips for avoiding heartaches, "510(k) Approval Timeline." There's some really good stuff there. Did you find those tips helpful? If you need more info, try the FDA's own site . . . The FDA's Information on Releasable 510(k)s: General Information Federal Register Notices Search the Releasable 510(k) Database Listing of CDRH Substantially Equivalent (SE) 510(k) Summaries or 510(k) Statements, for Final Decisions Rendered Downloadable 510(k) Files One gem is the FDA's "SCREENING CHECKLIST - ALL PREMARKET NOTIFICATION [510(k)] SUBMISSIONS" (free) that's used to assess whether your paperwork is complete enough or not for a substantive review. 

Previous 510(k) Posts: Medical Devices - A murky 510(k) world?! Medical Devices Containing Antimicrobial Agents - FDA Guidance Pending 

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