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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Drugmakers are pushing back against Australian draft guidance on batch release protocols, asking the Therapeutic Goods Administration (TGA) to allow authorized persons to release batches without access to the product’s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
Drugmakers are pushing back on proposed EU GMP requirements that would expand safeguards against product cross-contamination, saying the proposed six-month timeline for implementation is unworkable. Read More
The FDA Tuesday 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
President Barack Obama Nov. 27 signed into law a bill that establishes both a nationwide track-and-trace requirement for prescription drugs and a system of voluntary FDA oversight of compounding pharmacies. Read More