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Health care reform

Alston & Bird LLP
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USA
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October 28 2010

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

FTC issues proposed updates to rules on environmental marketing claims

Alston & Bird LLP
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USA
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October 28 2010

This month, the Federal Trade Commission (FTC) issued proposed modifications to update its so-called "Green Guides"-i.e., Guides for the Use of Environmental Marketing Claims found in 16 C.F.R. Part 260

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

Alston & Bird LLP
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USA
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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

Food safety reform

Alston & Bird LLP
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USA
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October 28 2010

As the 111th Congress comes to a close, comprehensive food safety reform remains unfinished due to Senate inaction resulting from member objections to the August manager's amendment to S.510

FDA issues new guidance on research not requiring an IND

Alston & Bird LLP
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USA
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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In October, FDA issued a draft guidance entitled "Investigational New Drug Applications (INDs) - Determining Whether Human Research Studies Can be Conducted Without an IND."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
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USA
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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
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USA
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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
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USA
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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
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USA
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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
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USA
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August 31 2010

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