Showing posts with label shortage. Show all posts
Showing posts with label shortage. Show all posts

Wednesday, August 19, 2020

Medical Device Shortages During the COVID-19 Public Health Emergency - FDA.gov

According to the FDA article:

"One provision of this new statutory authority—section 506J(g) of the FD&C Act— requires the FDA to maintain a publicly-available, up-to-date list of the devices the FDA has determined to be in shortage. In addition, the FDA is providing a list of medical devices for which the FDA has been notified that manufacturing has been permanently discontinued. The list below fulfills this statutory obligation and reflects the categories of devices the FDA has determined to be in shortage at this time, and will be maintained and updated as the COVID-19 public health emergency evolves."

Read the full source article, and view the list:  Medical Device Shortages During the COVID-19 Public Health Emergency - FDA.gov

Return to SkillsPlus International Info Blog - Home

-----------

FDA GMP QSR cGMP Online Training Courses by SkillsPlus International Inc.

SkillsPlus Intl Inc. - The Best GMP Training & cGMP Training Around
Free GMP Training Tips
Root Cause Analysis - GMP Training
Deviation Investigation Report Writing - GMP Training
Qualstar Simulation - Advanced GMP Training That's Fun!

 

Thursday, July 9, 2015

FDA Amends Drug Shortage Regulations


Read the full text final rule: Federal Register | Permanent Discontinuance or Interruption in Manufacturing of Certain Drug or Biological Products:

"The rule requires all applicants of covered approved drugs or biological products—including certain applicants of blood or blood components for transfusion and all manufacturers of covered drugs marketed without an approved application—to notify FDA electronically of a permanent discontinuance or an interruption in manufacturing of the product that is likely to lead to a meaningful disruption in supply (or a significant disruption in supply for blood or blood components) of the product in the United States."

'via Blog this'

Return to SkillsPlus International Info Blog - Home

SkillsPlus Intl Inc. - The Best GMP & QSR Compliance Training Around

Tuesday, November 5, 2013

FDA Proposal - Head Off More Drug Shortages

Updated December 19, 2020

You might be more interested in this:

- - -  original post follows below  - - -

FDA proposal aims to head off more drug shortages:

"The Food and Drug Administration announced a new proposal Thursday to try and head off more shortages of crucial medications that have disrupted care at hospitals and clinics nationwide.

Under the proposed rule, companies that make medically important prescription medicines would have to notify the FDA six months ahead of any changes that could disrupt the U.S. supply. That includes plans to discontinue a product or manufacturing changes that could slow production."

Return to SkillsPlus International Info Blog - Home

SkillsPlus Intl Inc. - The Best GMP & QSR Compliance Training Around