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FDA finalizes guidance document on OTC drug labeling

Reed Smith LLP
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USA
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January 12 2009

The FDA has issued final guidance on “Labeling OTC Human Drug Products Questions and Answers.”

FDA finalizes guidance document on evidence needed to substantiate dietary supplement claims

Reed Smith LLP
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USA
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January 12 2009

The FDA has released final guidance on “Substantiation for Dietary Supplement Claims Made Under Section 403(r)(6) of the Federal Food, Drug, and Cosmetic Act,” which discusses the amount, type, and quality of evidence that FDA recommends a dietary supplement manufacturer have to substantiate a nutritional deficiency, structurefunction, or general well-being claim

Posner on forum non conveniens

Reed Smith LLP
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USA
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May 4 2009

Over the centuries, many have sought better opportunities in the United States

Bi-annual update regarding pharmaceutical drug and medical device federal preemption: the Supreme Court speaks in Riegel v. Medtronic

Reed Smith LLP
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USA
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February 22 2008

Our last Biannual Preemption Update, published in October 2007, ended on a hopeful note about the drug and device preemption cases before the U.S. Supreme Court, and how such decisions might shape the defense and assist manufacturers

Current good manufacturing practice requirements for combination products

Reed Smith LLP
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USA
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September 23 2009

On September 23, 2009, the FDA published a proposed rule to codify current good manufacturing practice (cGMP) requirements that apply when drugs, devices, and biological products are combined to create a combination product

USEPA again targets antimicrobial products under FIFRA

Reed Smith LLP
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USA
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September 24 2009

On September 21, 2009, the U.S. Environmental Protection Agency filed a complaint against VF Corporation for the alleged sale and distribution of unregistered pesticides through its outdoor gear company, The North Face

FDA guidance documents

Reed Smith LLP
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USA
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September 23 2009

The FDA is accepting comments on the following new draft guidance documents for industry

FDA Commissioner Hamburg confirmed by Senate

Reed Smith LLP
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USA
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May 27 2009

On May 18, 2009, the Senate unanimously confirmed Dr. Margaret "Peggy" Hamburg as FDA Commissioner

FDA seeks comments on Presenting Risk Information in Prescription Drug and Medical Device Promotion

Reed Smith LLP
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USA
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May 27 2009

On May 27, 2009, the Food and Drug Administration (FDA) published a notice soliciting comments on a draft guidance document entitled "Presenting Risk Information in Prescription Drug and Medical Device Promotion."

FDA listing of drugs with potential safety issues

Reed Smith LLP
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USA
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February 11 2009

On February 4, 2009, the FDA posted updated listings of specific drugs that are being evaluated for potential safety issues based on a review of reports in FDA's Adverse Event Reporting System

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