Saturday, November 29, 2014

Thursday, November 20, 2014

FDA Law Blog: DOJ Announces Another GMP Consent Decree for a Dietary Supplement Manufacturer

Read the full article: FDA Law Blog: DOJ Announces Another GMP Consent Decree for a Dietary Supplement Manufacturer:

"These cases show that FDA will aggressively pursue violators of the dietary supplement GMP requirements.   Because the consent decrees include a recall provision, a shut-down provision, and a requirement that FDA confirm that they are in compliance before they can reopen, the companies may well end up being put out of business permanently.

FDA does not bring a lot of injunction cases per year.  Four (or more) injunctions related to dietary supplement GMP suggests that this area is a high enforcement priority for the Agency."

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Wednesday, November 19, 2014

FDA - News & Events > From our perspective: Assessing, safeguarding pharmaceutical quality

Read the full article: News & Events > From our perspective: Assessing, safeguarding pharmaceutical quality - FDA.gov

"Lucinda Buhse, PhD, acting director, Office of Testing and Research, Office of Pharmaceutical Science, discusses efforts underway in FDA’s laboratories to help assure high-quality drug products are available for the public."

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The article covers:
  • Assessing pharmaceutical quality
  • Measuring pharmaceutical quality across the drug lifecycle
  • FDA’s additional roles in safeguarding quality
  • Research and innovation in CDER’s drug quality testing program
  • Continuing to help protect consumers from harm
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Tuesday, November 11, 2014

FDA - Constituent Updates > New CFSAN Center Director Announced

Read the full article: Constituent Updates > New CFSAN Center Director Announced - FDA.gov:

"The U.S. Food and Drug Administration today announced a change in leadership at the Center for Food Safety and Applied Nutrition. In January 2015, Dr. Susan T. Mayne will take the reins from Michael M. Landa, who has led the Center since 2010, providing critical leadership on major food safety and nutrition initiatives.

Mayne is an internationally recognized public health leader and scientist, who is also known as an outstanding administrator and coalition builder. With rigorous training in nutrition, toxicology, and epidemiology, she understands the fundamental relationship between science and FDA’s public health mission"

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Thursday, November 6, 2014

It's Not Just You: FDA Regulatory Requirements Really Are Increasing | RAPS

Read the full article: It's Not Just You: FDA Regulatory Requirements Really Are Increasing | RAPS:

"According to data made available by George Mason University's Mercatus Center and analyzed by Regulatory Focus, the number of regulatory requirements imposed by the US Food and Drug Administration (FDA) increased by 15% between the years 2000 and 2012.

While regulatory professionals working with FDA needed to know just 16,329 requirements in 2000, they needed to know 18,777 in 2012, according to the data."

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