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Beginning with today's issue, your FDAnews publication will be delivered to you in a new, interactive PDF format designed to eliminate the need for scrolling through the document to find a story or to read the continuation of an article.
Beginning with today's issue, your FDAnews publication will be delivered to you in a new, interactive PDF format designed to eliminate the need for scrolling through the document to find a story or to read the continuation of an article.
Endo Pharmaceuticals has reached an agreement with the FDA on the design of a new clinical trial to confirm the safety and efficacy of its experimental pain drug, oxymorphone extended-release (ER) tablets, the firm said yesterday.
The FDA has denied a citizen petition calling for the removal of Bristol-Myers Squibb’s (BMS’) antidepressant Serzone because of safety concerns — a move that allows generic firms to continue to market the drug, which no longer is sold by BMS.
The FDA has denied citizen petitions submitted by two prominent generic drugmakers seeking to prohibit the marketing of authorized generic drugs during another generic firm's 180-day exclusivity period.
A key Republican lawmaker is urging the General Accounting Office (GAO) to conduct a broad review of the FDA’s drug safety arm, saying he is concerned that a department charged with protecting the public interest appears to be a “lapdog” with little independence.