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  • Regulatory NewsRegulatory News

    Petition Calls on FDA to Pull All Fluoride Supplements From the Market

    The Fluoride Action Network (FAN) and the International Academy of Oral Medicine & Toxicology (IAOMT) are calling on the US Food & Drug Administration (FDA) to expedite the removal from the market all unapproved, unsafe, unnecessary and ineffective sodium fluoride-containing drops, tablets and lozenges sold for the intended purpose of preventing tooth decay. The petition, submitted to FDA on Monday, follows the agency’s issuance of a warning letter in January to Kirkma...
  • Regulatory NewsRegulatory News

    FDA Raises Questions Over DTC Genetic Tests Offered at Rite Aid

    The US Food and Drug Administration (FDA) called out another direct-to-consumer (DTC) genetic testing company on Monday over an unapproved test, this time going after one recently made available at the drugstore chain Rite Aid. According to the letter from FDA, the swab tests from Tennessee-based Harmonyx, a College of American Pathologists-accredited and Clinical Laboratory Improvement Act-certified genetic testing laboratory, are meant to help patients determine if the...
  • Untitled Letter Cites BMS for Alleged Misbranding

    • 18 July 2012
    • By
    Pharmaceutical manufacturer Britsol-Myers Squibb was the recipient of an Untitled Letter from the US Food and Drug Administration's (FDA) Office of Prescription Drug Promotion (OPDP) regarding marketing materials for its drug Ixempra (icabepilone). In the Untitled Letter , FDA calls a sales aid for Ixempra , submitted to the agency for review by BMS, as misleading due to "unsubstantiated efficacy claims" and an implied indication broader than the one approved by the ag...
  • Senators Call out Pharmacy For Potentially Promoting Supplements Over FDA-Approved Products

    US Senators Dick Durbin (D-IL) and Richard Blumenthal (D-CT) called upon pharmacy retailer Rite Aid for "potentially deceptive marketing practices […] that could mislead consumers seeking medical advice and direct customers to treat health conditions with dietary supplements." The Senators expressed their concerns in light of accounts that the company has "wellness stations" situated near pharmacy counters which sport consultants donning white jackets that are rep...