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Pharmaceutical Industry › Food and Drug Administration (FDA) › Abbott Laboratories

Console and Associates, P.C.

The Use of Depakote by Pregnancy Women Linked to Serious Birth Defects

Console and Associates, P.C. on

Over ten years ago, the Food and Drug Administration (FDA) determined that pregnant women who take Depakote (valproate) have a much higher chance of giving birth to a baby who suffers low IQ or a birth defect. In response,...more

Arnall Golden Gregory LLP

AGG Food & Drug Newsletter - April 2016

Arnall Golden Gregory LLP on

Arnall Golden Gregory LLP's (AGG) Food and Drug Newsletter is a monthly update of legal and regulatory issues that affect the FDA-regulated community, including regular updates on legislative initiatives from AGG’s...more

Wilson Sonsini Goodrich & Rosati

District Court Holds That FDCA Does Not Prohibit and Criminalize Truthful Off-Label Promotion of FDA-Approved Prescription Drugs

Wilson Sonsini Goodrich & Rosati on

On August 7, 2015, the U.S. District Court for the Southern District of New York released its Amarin opinion addressing whether truthful, non-misleading off-label promotion of U.S. Food and Drug Administration (FDA)-approved...more

Morrison & Foerster LLP

Jury Buys Plaintiff’s Argument That Drug Manufacturer Should Have Distributed Dear Doctor Letter Sooner, Without Prior FDA...

Morrison & Foerster LLP on

Dear Doctor letters were front and center in the just-tried case of Tietz v. Abbott Laboratories, Inc., et al., No. 12-L-002715. On Thursday, May 9, 2013, a Chicago jury returned a $2.2 million verdict in favor of the...more

McDonnell Boehnen Hulbert & Berghoff LLP

WLF Submits Comments on Abbott's Citizen Petition on Biosimilars

McDonnell Boehnen Hulbert & Berghoff LLP on

Last April, Abbott Laboratories filed a Citizen Petition with the U.S. Food and Drug Administration, asking the agency to refrain from accepting biosimilar applications under the Biologics Price Competition and Innovation Act...more

BakerHostetler

No Standing for Illegal Drugs: Third Circuit Limits Antitrust Standing for Foreign Drug Manufacturers Absent FDA Approval

BakerHostetler on

A Third Circuit panel recently ruled that a foreign drug manufacturer lacks antitrust standing when it could only sell its product in the United States through a distributor....more

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