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PhRMA has adopted new voluntary principles to encourage drugmakers to release comprehensive data about clinical trials, amid growing controversy about the suppression of negative trial results.
Pfizer and the FDA’s Office of Criminal Investigations are investigating confirmed reports of counterfeit Viagra sold in two pharmacies in Glendale and Fresno, Calif.
Generic firm Mylan Laboratories is urging the FDA to immediately clarify its position on authorized generics — a move that will likely prompt a lawsuit from either the brand or generic industry.
Final action on a rule governing labeling for human prescription drugs is set for October, according to the FDA’s Semiannual Regulatory Agenda, published in the Federal Register earlier this week.
The FDA said it will make available $300,000 in grant funds for the State Health Fraud Task Force Grant Program to assist states in enforcing drug- and healthcare-related laws.
The national association representing pharmaceutical benefit managers (PBMs) has filed suit seeking to block the District of Columbia from enforcing a law requiring PBMs to disclose what the association considers proprietary information.
The FDA should use its currently accepted criteria for demonstrating bioequivalency to approve generic versions of McNeil Consumer & Specialty Pharmaceuticals’ attention deficit/hyperactivity disorder drug Concerta, argued a law firm in response to a McNeil citizen petition that has delayed generic entry.
The FDA has issued an approvable letter for Pfizer’s new drug application for Cardura XL, a sustained-release formulation of doxazosin mesylate that will be marketed by generic firm Andrx.