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FDA reverses course on drug pedigrees: pedigrees no longer required back to manufacturer

Reed Smith LLP
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USA
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July 22 2011

On July 14, 2011, the Food and Drug Administration (“FDA” or “Agency”) proposed to permit wholesale distributors to document the chain of custody (also known as a drug “pedigree”) of prescription drug products only back to the last authorized distributor of record (“ADR”), instead of all the way back to the manufacturer

FDA proposes changes to Orphan Drug Regulations

Reed Smith LLP
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USA
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October 21 2011

On October 19, 2011 the Food and Drug Administration published a proposed rule in the Federal Register that would amend the 1992 Orphan Drug Regulations issued to implement the Orphan Drug Act

FDA launches "Bad Ad Program" to help health care providers detect, report misleading drug ads

Reed Smith LLP
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USA
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May 12 2010

On May 11, 2010, the U.S. Food and Drug Administration (FDA) launched a new initiative the “Bad Ad Program” designed to educate health care practitioners about their role in ensuring that prescription drug advertising and promotion is truthful, and not misleading

Draft FDA guidance on exculpatory language in informed consent

Reed Smith LLP
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USA
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September 26 2011

The HHS Office for Human Subject Protections (OHRP) and the Food and Drug Administration (FDA) are seeking comments on a joint draft document entitled “Guidance on Exculpatory Language in Informed Consent"

Prescription drug and medical device promotion new FDA draft guidance on presenting risk information

Reed Smith LLP
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USA
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June 2 2009

On May 27, 2009, the Food and Drug Administration ("FDA") announced the availability of a draft guidance titled Presenting Risk Information in Prescription Drug and Medical Device Promotion ("Draft Guidance"

FDA’s emerging internet policy: themes and recommendations from public hearing on promotion of FDA-regulated medical products using the internet and social media tools

Reed Smith LLP
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USA
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November 27 2009

Following a decade-long hiatus, the Food and Drug Administration ("FDA") appears ready to finally address industry Internet communications

IOM recommendation for greater FDA authority on post-market surveillance

Reed Smith LLP
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USA
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May 25 2010

The Institute of Medicine (IOM) has issued a report recommending that Congress grant FDA greater authority to require post-market surveillance of medical products approved primarily on the basis of surrogate endpoints

Convergence of communications and medical systems: the opportunities and the challenges

Reed Smith LLP
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USA
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June 18 2010

The Federal Communications Commission (FCC) just announced that, as part of its implementation of the recently released National Broadband Plan and the Plan's recommendation to use the power of broadband to improve healthcare, the FCC and the Food and Drug Administration (FDA) are going to be holding a public meeting on July 26 and 27, 2010, to discuss regulatory issues arising from the convergence of wireless technology and healthcare devices

FDA meeting and request for comments on generic drug user fee program

Reed Smith LLP
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USA
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August 13 2010

FDA will hold a public meeting on September 17, 2010 to seek input on the development of a generic drug user fee program

FDA announces medical device user fees for FY 2011, upcoming meeting (Sept. 12)

Reed Smith LLP
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USA
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August 13 2010

FDA announced the medical device user fees for FY 2011, which covers October 1, 2010 - September 20, 2011

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