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Results: 1-10 of 14

Health care reform

  • Alston & Bird LLP
  • -
  • USA
  • -
  • October 28 2010

September 23 marked the six-month anniversary of the enactment of health care reform

The future of medical product approvals: parallel review by FDA and CMS?

  • Alston & Bird LLP
  • -
  • USA
  • -
  • October 28 2010

Last month, FDA and the Centers for Medicare and Medicaid Services (CMS) issued a Federal Register notice soliciting comments on a proposal to establish a process for the parallel review of drugs and devices for FDA marketing approval or clearance and CMS national coverage determinations (NCDs

FDA issues new guidance on research not requiring an IND

  • Alston & Bird LLP
  • -
  • USA
  • -
  • October 28 2010

In October, FDA issued a draft guidance entitled "Investigational New Drug Applications (INDs) - Determining Whether Human Research Studies Can be Conducted Without an IND."

OHRP guidance on data retention and the withdrawal of subjects from research

  • Alston & Bird LLP
  • -
  • USA
  • -
  • October 28 2010

On September 21, the HHS Office for Human Research Protections (OHRP) published guidance on the withdrawal of subjects from human research

Closing comment periods of note

  • Alston & Bird LLP
  • -
  • USA
  • -
  • October 28 2010

FDA is seeking comments on draft guidance entitled "Suicidality: Prospective Assessment of Occurrence in Clinical Trials."

FDA-related issues in the OIG 2011 Work Plan

  • Alston & Bird LLP
  • -
  • USA
  • -
  • October 28 2010

The Office of Inspector General (OIG) recently released its Fiscal Year (FY) 2011 Work Plan

Off-label promotion enforcement update

  • Alston & Bird LLP
  • -
  • USA
  • -
  • October 28 2010

As if drug and device companies did not have enough to worry about in the wake of numerous "fraud and abuse" lawsuits brought by the government, FDA is now signaling greater emphasis on criminal prosecutions for off-label promotion

Examination of the medical countermeasures enterprise: FDA's initiatives to speed development of medical countermeasures

  • Alston & Bird LLP
  • -
  • USA
  • -
  • August 31 2010

The U.S. Department of Health and Human Services (HHS) recently released a report on its examination

Generic drug user fee program: coming soon?

  • Alston & Bird LLP
  • -
  • USA
  • -
  • August 31 2010

On September 17, FDA will hold a public meeting to begin gathering stakeholder input on the implementation of a generic drug user fee program

Use of a centralized institutional review board

  • Alston & Bird LLP
  • -
  • USA
  • -
  • August 31 2010

On April 30, 2010, the Office for Human Research Protections (OHRP) published a letter responding to a medical center's question regarding the use of a central institutional review board (IRB