Topics and Expertise: Food and Drug Administration (FDA)

Feature articles shine spotlight on Kidney Project

The San Francisco Chronicle and the Bay Area News Group, which includes the San Jose Mercury News and Oakland Tribune, have published feature articles this week focused on The Kidney Project, an effort to develop the first implantable bioartificial kidney to treat end-stage renal disease.

Self care group supports researching non-prescription access by patients to urgent and chronic care drugs

On March 22 and 23, 2012, the U.S. Food and Drug Administration (FDA) held a public hearing to explore the idea of switching some medications to treat chronic conditions and health emergencies from prescription to over- and behind-the-counter status.

Soller defines the roadmap for Rx-to-OTC switches

If you are a pharmaceutical company seeking to switch your prescription medication to one sold directly to consumers—as an over-the-counter or OTC drug—William Soller, PhD, has your road map.

Drug information resources may miss parts of boxed warnings

An analysis by UCSF faculty members from the Schools of Pharmacy and Medicine has found that the half-dozen most reputable electronic drug information resources—tools commonly used by clinicians to make prescription and patient monitoring decisions—may not provide key elements of some medications’...

Prioritizing drug label warnings called for by UCSF School of Pharmacy authors

In the current issue of The Archives of Internal Medicine, two faculty members of the UCSF School of Pharmacy, Department of Clinical Pharmacy issue a call for prioritization in prescription labels’ increasingly long lists of adverse drug events (ADEs).

Symposium on the future of therapeutics inaugurates new UCSF department

In the first symposium held by the newly minted UCSF Department of Bioengineering and Therapeutic Sciences, researchers described progress in the fields of systems biology, pharmacogenomics, and bioengineering, and how scientists in these fields are working in concert to develop novel diagnostics an

Study identifies lack of information about HER2 testing practices

Breast cancer patients might not be getting full advantage from a genetic screening test for the protein known as HER2 to help determine if the use of trastuzumab (marketed as Herceptin) is the best course of treatment for them. For patients whose breast cancer cells produce excessive amounts of...

Soller comments on acetaminophen

William Soller, PhD, UCSF faculty member and expert on food and drug law and regulations comments on the June 30, 2009 vote of a US Food and Drug Administration (FDA) advisory committee to lower the US maximum over-the-counter dose of acetaminophen and make the curren

Plan B under review again by the FDA

In light of the US Food and Drug Administration (FDA) July 31, 2006 announcement that it is proceeding to work toward making emergency contraception, known as Plan B, a non-prescription product for women ages 18 and older, two UCSF School of Pharmacy c

Pages