In 2003 the Texas Legislature provided a presumption that a manufacturer is not liable for a claim that it failed to provide adequate warnings for a pharmaceutical product if the product was approved by the Food and Drug…more
Par filed suit seeking a judgment declaring FDA’s regulations unconstitutional and preventing FDA from deeming lawful First Amendment protected speech as evidence of criminal intent. In response, FDA is seeking early dismissal,…more
On December 27, 2011, FDA issued its Draft “Guidance for Industry Responding to Unsolicited Requests for Off-Label Information about Prescription Drugs and Medical Devices.” This long sought Draft Guidance breaks little new…more
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