The FDAnews report EU MDR Compliance can help. Our editors have combed through the regulations, picking out the most minute compliance points and building them into a checklist of 200+ requirements you can use to confirm that you are satisfying all the EU mandates for device manufacturing.
China cleared the way for the U.S. Food and Drug Administration to add 10 new drug investigators to its local roster, following a Dec. 4 meeting between U.S. Vice President Joe Biden and Chinese President Xi Jinping. Read More
Drugmakers and the FDA have different ideas about the proper scale for the agency’s quality metrics program. While industry supports collecting data on no more than four metrics, the FDA promises only that it will monitor no more than 16. Read More
The FDA issued a Form 483 to Biogen Idec that cites a weakness in the way the company manages suppliers, highlighting the difficulties drugmakers continue to have with supplier quality issues. Read More
The FDA may refine its planned quality metrics program to include rankings of individual drugmaker quality — at the request of industry — that will show how a company’s quality system stacks up against its peers. Read More
The FDA is demanding Wockhardt investigate whether management was involved in quality data manipulation at its Chikalthana, India, facility before the agency will lift the import ban it has slapped on the plant. Read More
CDER Director Janet Woodcock has decided to head the FDA’s new Office of Pharmaceutical Quality (OPQ) herself until it gets off the ground. The new office is planned as a “super office” that will oversee manufacturing quality throughout a drug’s lifecycle. Read More
The FDA wants Wockhardt to investigate whether management was involved in quality data manipulation at its Chikalthana, India, facility before the agency will lift an import ban it slapped on the plant Nov. 26. Read More