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FDA solicits comments on CDER research needs report
  • Shook Hardy & Bacon LLP
  • USA
  • July 28 2011

The Food and Drug Administration (FDA) has issued for public comment a report prepared by the Center for Drug Evaluation and Research (CDER) identifying “current priorities in regulatory science related to CDER’s mission.”

Article claims FDA “provides scant oversight” in medical device monitoring
  • Shook Hardy & Bacon LLP
  • USA
  • November 11 2010

According to a recent article on the effectiveness of post-market surveillance, medical device manufacturers "often fail to properly conduct safety studies" and the Food and Drug Administration (FDA) "provides scant oversight" in post-approval monitoring of these devices.

FDA orders recall and destruction of infusion pumps
  • Shook Hardy & Bacon LLP
  • USA
  • May 13 2010

The Food and Drug Administration (FDA) has ordered a medical device manufacturer to recall and destroy some 200,000 infusion pumps currently in use in hospitals and health care clinics to accurately deliver fluids, such as nutrients and medications, into a patient's body.