Showing posts with label regulatory. Show all posts
Showing posts with label regulatory. Show all posts

Wednesday, June 29, 2022

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Wednesday, February 4, 2015

What Timeless Advice Would You Give to a Regulatory Rookie? | FDAZILLA BLOG

Read the article, including the advice:  What Timeless Advice Would You Give to a Regulatory Rookie? | FDAZILLA BLOG:

"Sometimes we get emails from people who are just starting out in the field of regulatory, quality, and compliance, asking us – what advice do we have for new people to get onto the right path?"

'via Blog this'

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Monday, March 11, 2013

FDA Focusing On Food & Drug Manufacturing GMP Compliance

Updated December 9, 2021

Links in the original post broke.

You might also like:

---  the original post follows below  ---

FDA is focusing on cGMP compliance by food and drug manufacturers.

FDA investigative chief eyes manufacturing practices:

"John Roth, director of the FDA's Office of Criminal Investigations, said officials are seeking to ensure that companies are appropriately balancing their profit motives with the need to manufacture food and drugs responsibly.

The meningitis outbreak and other recent cases have spurred the agency to take a closer look at this balance, Roth told lawyers at an American Bar Association-sponsored conference in Las Vegas focused on white-collar crime.

"We wonder exactly if this is a systemic problem, if it requires a broader response by the FDA or is it an anomaly," Roth said in a panel discussion Friday. "We're going to be taking a look at that and hopefully we'll launch in a thoughtful way.""

'via Blog this'

You might also be interested in:
On the FDA website - FD&C Act Chapter III: Prohibited Acts and Penalties

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Monday, December 19, 2011

2012 Crystal Ball Predicts a More Aggressive FDA

Updated February 2, 2021

Links in the original post broke.

- - -  the original post follows below  - - -

2012 Crystal Ball Predicts a More Aggressive FDA
:
"According to the FDA website, 2012 will be a year of global regulatory operation and enforcement with emphasis on medical devices, drugs, and food products. "
'via Blog this'

The article references:
The FDA Pathway to Global Product Safety and Quality

It's hard to believe 2011 is nearly over, and 2012 is around the corner.  Here's to future trends!

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Thursday, November 3, 2011

FDA Awards Two New Regulatory Research Centers

Photograph of the Taxus drug-eluting stent, fr...Image via WikipediaFDA launches two centers to improve approval of drugs, devices - The Hill's Healthwatch:  'via Blog this'

"The Food and Drug Administration (FDA) on Wednesday awarded $2 million to support the creation of research centers tasked with improving the way new medicines and medical devices are reviewed and evaluated."

The centers will be established at the University of Maryland and Georgetown University.

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