Food Drug & Devices

User fee waiver request draft guidance revised

User fee waiver or reduction requests were revised in a draft guidance published by the FDA for applicants considering the process. Titled “User Fee Waivers, Reductions, and Refunds for Drug and Biological Products,” the revised draft guidance describes the types of waivers and reductions permitted under the user fee provisions of the FDC Act, and […]

Medication guides in outpatient settings, draft guidance

Medication Guides should be dispensed in outpatient settings, even when the drug is dispensed to a healthcare professional for administration to the patient, the first time the drug is dispensed, and if the Medication Guide is materially changed, according to a draft guidance published by the FDA. Titled “Medication Guides— Distribution Requirements and Inclusion in […]

Weight control drug product reclassified

Benzocaine would be reclassified from its previously proposed monograph status (category I) for over-the-counter (OTC) weight control use to nonmonograph status in a proposed rule by the FDA. An approved new drug application (NDA) or abbreviated new drug application (ANDA) for the marketing of OTC weight control products containing benzocaine would be required, because agency […]

Food, Drugs & Device Update – April 2011

Topic of the Month: In Mid-April, the White House unveiled a multi-agency plan aimed at reducing the “epidemic” of prescription drug abuse in the U.S. — including an FDA-backed education program designed to reduce the misuse and misprescribing of opioids. Opioids are synthetic versions of opium that are used to treat moderate and severe pain. […]

Food, Drugs & Device Update – March 2011

Topic of the Month: With the widespread devastation in northern Japan caused by a magnitude 9.0 earthquake on March 11, 2011, and the resulting damage at the Fukushima Daiichi nuclear power plant, the FDA noted that its current screening at U.S. borders will be augmented with radiation screening of shipments. On March 22, 2011, to […]