The Food and Drug Administration's director of the Center for Drug Evaluation and Research, Janet Woodcock, on Thursday identified three tools the agency wanted to use in potentially increasing access to appropriate medicines in her opening remarks at the FDA Rx-to-OTC Switch Hearing.
GlaxoSmithKline on Thursday morning presented exactly how technology might improve appropriate patient self-selection before a panel convened by the Food and Drug Administration to explore expanding the prescripton-to-over-the-counter switch paradigm by incorporating technology and/or pharmacy participation in the application process.
"Dateline NBC" on Sunday aired an exposé concerning certain outliers of the dietary supplement industry during its "Hansen Files" segment featuring Chris Hansen, charging that supplement manufacturers aren't ensuring that those ingredients on their labels are actually in the supplement.
Forest Labs has filed suit against Glenmark Generics and several other companies, alleging that they infringed on its patent for a drug to treat hypertension by seeking regulatory approval for generic versions.
One of the long-term goals of many drug companies has been to win Food and Drug Administration approval for cholesterol-lowering statins as over-the-counter drugs. But it's a goal that has long eluded them due to the agency's concerns about patient safety.
A Food and Drug Administration panel will meet Monday to discuss a class of drugs designed to treat chronic painful conditions that currently are under development and the safety issues possibly related to the drugs.
Written testimony submitted by the National Association of Chain Drug Stores underscored chain pharmacies’ commitment to patient safety as part of the next Prescription Drug User Fee Act reauthorization, and emphasized that community pharmacist-provided services help improve health outcomes without the introduction of unproven technologies.
The Cosmetic Ingredient Review, an independent panel of scientific and medical experts, reaffirmed this week at its public meeting that parabens, a family of preservatives used in cosmetics and personal care products, are safe, the Personal Care Products Council announced on Wednesday.