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

HHS has approved the overhaul of the FDA's Office of Generic Drugs (OGD), allowing the agency to move most of its functions relating to generic drugs under one roof. 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

Chinese officials have cleared the way for the FDA to station 10 additional drug and device investigators in China. 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

With the new pharmaceutical track-and-trace law’s deadline for lot-level pedigrees looming, the FDA is still unclear about how it will regulate the complex requirement. Read More

Drugmakers are pushing back against Australian draft guidance on batch release protocols, asking the Therapeutic Goods Administration (TGA) to allow authorized persons to release batches without access to the product’s complete marketing application. Read More

The FDA is building a list of difficult-to-manufacture drugs that compounders will not be allowed to make and is soliciting public suggestions for products to place on the list. 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

The FDA Nov. 27 hit Wockhardt with a second “import alert,” banning drug products from its Chikalthana plant in western India — the latest in a spate of regulatory actions taken against the struggling drugmaker. Read More

Just days after the FDA’s new authorities over compounding pharmacies was signed into law, the agency Monday issued draft guidances detailing how facilities register and report product information to the FDA. Read More