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Waxman bill brings controversial new concepts and questions to biosimilars debate

Wiley Rein LLP
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USA
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March 13 2009

On March 11, 2009, Congressman Henry Waxman (D-CA) introduced the latest version of a bill to provide for an abbreviated FDA approval pathway for "biosimilar" or "biogeneric" versions of innovator biological drug products

First Amendment case may doom state health care laws

Wiley Rein LLP
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USA
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January 4 2011

State health care laws in Maine, Vermont, and New Hampshire took a hit recently when the U.S. Court of Appeals for the Second Circuit overturned a Vermont law that restricted pharmaceutical company access to privately collected prescribing data for physicians practicing in the state

FDA launches "Bad Ad" Program - DDMAC seeks enforcement help from health care providers

Wiley Rein LLP
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USA
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May 12 2010

Citing a limited ability to identify violative pharmaceutical advertising and promotional activities, the Food and Drug Administration (FDA) has announced the launch of its "Bad Ad" Program

FDA transparency proposal would scrap longstanding trade secret protections

Wiley Rein LLP
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USA
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May 20 2010

On May 19, 2010, the U.S. Food and Drug Administration's (FDA) Transparency Task Force, chaired by Principal Deputy Commissioner Joshua Sharfstein, issued a report containing 21 specific proposals to improve agency transparency across a variety of agency activities

Indictment of former drug company lawyer, other FDA prosecution threats, turn up the heat on FDA-regulated companies and their employees

Wiley Rein LLP
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USA
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November 15 2010

On November 9, 2010, federal prosecutors indicted a retired associate general counsel of GlaxoSmithKline on criminal charges of obstruction and making false statements in connection with a Food and Drug Administration (FDA) investigation into alleged "off-label" promotion of a prescription drug product

Court to weigh viability of state suits over generics

Wiley Rein LLP
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USA
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March 14 2011

On March 30, the U.S. Supreme Court will hear argument in three consolidated cases involving injury allegedly caused by generic versions of the prescription drug Reglan (metoclopramide): Pliva v. Mensing, U.S., No. 09-993, Actavis Elizabeth LLC v. Mensing, U.S., No. 09-1039, and Actavis Inc. v. Demahy, U.S., No. 09-1501

FDA menu nutrition labeling requirements will mean significant changes for chain restaurants

Wiley Rein LLP
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USA
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April 18 2011

Efforts by the Food and Drug Administration (FDA) to implement the restaurant menu labeling and vending machine labeling provisions of the Patient Protection and Affordable Care Act of 2010 (Act) took a major step forward with the publication of the FDA's proposed regulations on April 6, 2011

First biosimilars guidances issued by FDA

Wiley Rein LLP
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USA
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February 9 2012

On February 9, 2012, the Food and Drug Administration (FDA) issued the first three draft Guidances on the development and approval processes for biosimilar products under the Biologics Price Competition and Innovation Act of 2009 (BPCIA

FDA extends comment period on controversial cost burden analysis of proposed Unique Medical Device Identifier System

Wiley Rein LLP
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USA
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September 19 2012

On Monday, September 17, 2012, the Food and Drug Administration (FDA) announced an extension of the comment period on the cost burden estimates for the Unique Device Identifier System Proposed Rule

First Amendment defense prevails against FDA prosecution for off-label marketing

Wiley Rein LLP
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USA
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December 3 2012

In an important 2-1 decision overturning the criminal conviction of a pharmaceutical sales representative, a panel of the U.S. Court of Appeals for the Second Circuit in U.S. v. Caronia, today reset the legal boundaries between the Food and Drug Administration's (FDA) regulatory authority and pharmaceutical manufacturers’ rights to disseminate “off-label” information about approved drug products

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