ANN ARBOR, MI — For nearly two years, the Food and Drug Administration has been issuing safety advisories about the risks of abnormal heart rhythms with higher doses of the antidepressant citalopram hydrobromide.

WASHINGTON — What should FDA’s role be in the continuing globalization of the prescription drug market, and should the agency be obligated to consider the health of the American pharmaceutical industry in any decisions it makes?

WASHINGTON — Unless FDA knows of a potential drug shortage in advance, the agency is not very effective in preventing or controlling that shortage, according to a recent government report.

WASHINGTON — Controversy over access to birth control is continuing with the Department of Health and Human Services’ recent decision to cover birth control as a preventive service under the Affordable Care Act.

WASHINGTON — Six months after the Institute of Medicine (IoM) issued a report recommending the dissolution of FDA’s 510(k) medical device approval process, the agency has yet to release their official response — a delay that has legislators concerned.

WASHINGTON — FDA needs the authority to keep foreign manufacturers who do not comply with regulatory requests from importing their products into the United States, agency officials are telling legislators.

WASHINGTON — The number of drug shortages reported annually has nearly tripled over the last five years, with much-needed drugs such as chemotherapy, anesthetics and electrolytes disproportionately affected.

Please read this article and participate in this month's online opinion poll about whether pharmaceutical manufacturers should be required to inform FDA six months in advance if they are discontinuing any drug?

WASHINGTON — Since taking office, FDA Commissioner Margaret Hamburg, MD, has pushed for science to play a stronger role in the agency, both in the rationale for its decision-making and in meeting its basic purpose.

BETHESDA, MD—Even drugs that have been on the market for years, sometimes decades, are not immune from reexamination and relabeling brought about by new scientific discoveries. In the field of pharmacogenomics especially, new opportunities are presenting themselves to use new science to improve drug safety and dosing protocols.

WASHINGTON, DC—While the overall negative health effects of smoking have been common knowledge for many years, a newly-released Surgeon General’s report goes into unprecedented detail on how tobacco causes disease at a biological and behavioral level.