News

Latest News | 11 January 2013

Regulation on Research Misconduct Withdrawn by FDA

0 Likes

The US Food and Drug Administration (FDA) has withdrawn a final rule that it had published just a few months ago, saying that it will once again allow access to records regarding scientific research Read More...

---

Latest News | 4 January 2013

In Unusual Move, FDA Withdraws OMB Submission to Focus on Changes to Device Program

0 Likes

If you're waiting for the US Food and Drug Administration's (FDA) guidance on planned changes to its medical device pre-submission meeting program, you may have to wait a bit longer.In a highly Read More...

---

Latest News | 4 October 2012

Teva Withdraws Antidepressant After Bioequivalence Concerns Validated by FDA

1 Likes

The US Food and Drug Administration (FDA) has asked Israeli generic drug manufacturer Teva Pharmaceuticals to stop distribution of Budeprion XL 300, a generic version of the antidepressant Wellbutrin Read More...

---

Latest News | 27 June 2012

FDA: Blood Products Policy Guide 'Obsolete'

0 Likes

The US Food and Drug Administration (FDA) has withdrawn its compliance policy guide (CPG) governing the registration of blood banks and other companies  that prepare human blood and blood products—the Read More...

---

Latest News | 14 June 2012

FDA Moves to Reduce Backlog of ANDAs

1 Likes

The US Food and Drug Administration (FDA) is moving to clear a massive backlog of abbreviated new drug applications (ANDAs), used by companies looking to market generic versions of FDA-approved Read More...

---