Indian regulator says his agency will not expect domestic drugmakers to hit FDA standards

FDA Commissioner Margaret Hamburg returned from her trip to India talking up cooperation and collaboration between regulators there and the FDA. Not all regulators there, however, sounded as enthusiastic as she did. Hamburg said that India's involvement the U.S. drug market "is why it is so important that the Indian regulator really joins us at the table." But G.N. Singh, the Drug Controller General of India, told Reuters that while he sees some areas for cooperating on more stringent manufacturing standards, "We don't recognize and are not bound by what the U.S. is doing and is inspecting." Story | More

Suggested Articles

The future may be uncertain for AZ’s Imfinzi in first-line lung cancer, but its targeted med Tagrisso now boasts a green light in that setting.

Ultragenyx is back with another FDA nod, this time for Crysvita to treat X-linked hypophosphatemia in patients one year and older.

Roche got a two pieces of good Hemlibra news early this week—and what's good for Hemlibra must be good for Roche.