Tag Archives: Warning Letters

Live from DIA: FDA Warning Letters Stir More Questions Than Answers

By George Koroneos | Published: June 23, 2009
A panel of regulators from FDA’s Division of Drug Marketing, Advertising, and Communications were taken to task, this morning at the Drug Information Association’s annual meeting, for 14 warning letters levied on drug companies for not including risk information in online search ads. A Sanofi Aventis employee complained about the 14 warning letters and asked why [...]
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Nine Pharmas Warned for Selling Unapproved Pain Drugs

By George Koroneos | Published: March 31, 2009
FDA, this morning, sent warning letters to nine pharmaceutical companies that are manufacturing and marketing 14 unapproved pain tablets. The drugs in question are prescription unapproved products that include high concentrate morphine sulfate oral solutions and immediate release tablets containing morphine sulfate, hydromorphone, or oxycodone. The letters stated that the drug firms must cease and desist [...]
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