FDA Commish asks for more power over compounding

As FDA Commissioner Margaret Hamburg prepared to testify before Congress about the deadly meningitis outbreak, reports surfaced that the agency wanted to shut New England Compounding Center down to fix manufacturing violations in 2003, but deferred to state regulators who apparently dropped the ball. Hamburg was expected to call for broader FDA authority to combat future compounding problems. Report | Report

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.