Category Archives: FDA
By Reid Paul | Published: March 19, 2013
brightcove.createExperiences(); To read the March cover story in the PharmExec digital edition, click here.
By Clark Herman | Published: March 15, 2013
Last week, the United States Center for Disease Control (CDC) and Britain’s Chief Medical Officer issued separate warnings about the urgent problem of antibiotic resistance in infectious diseases. Given industry’s general lack of interest in developing new antibiotics to address this problem, the warnings indicate that a discussion is needed around which incentives and regulatory [...]
By Jill Wechsler | Published: March 15, 2013
After less than a year on the job, the head of FDA’s Office of Generic Drugs (OGD) has announced his departure, a sign that all is not well with plans for major organizational changes at the Center for Drug Evaluation and Research (CDER).
By Jill Wechsler | Published: March 12, 2013
The greatly feared federal budget sequestration mandate went into effect March 1, and, initially, the impact was fairly muted. The stock market soared, employment rose and government workers continued on their jobs. Federal agencies, including the Food and Drug Administration (FDA), launched initiatives to comply with the mandated 5% across-the-board cut in spending (in reality [...]
By Ben Comer | Published: March 8, 2013
The Office of Prescription Drug Promotion (OPDP) is reorganizing its two primary advertising review divisions – professional and consumer – in an attempt to stay in line with the silo-breaking, multi-channel promotional output pouring in from pharma. The line between physician marketing and consumer marketing has blurred as the facets of a brand campaign – from [...]