Regulatory Affairs

Wockhardt CEO Says Company Will Resolve Form 483 Issues

Wockhardt’s CEO Habil Khorakiwala has characterized the FDA’s recent findings of nine Form 483 observations at its manufacturing plant in Shendra, India as minor, and predicted that the agency’s concerns would be resolved within a few months. Read More

FDA Asked to Take a World View on CMC Controls

Drugmakers have asked the FDA to think “globally” with the international community as they weighed in on the agency’s draft guidance on established conditions for reporting chemical, manufacturing and control changes. Read More