If the recent Science Board report on science within the Agency wasn't enough and you needed more evidence of the urgent need for better IT infrastructure, staffing and other resources for FDA, the Wall Street Journal released this bombshell this morning. Click here to read.
The drive-through, an American institution, is now under fire. With many Americans unwilling to get out of their cars - banks, restaurants and even Las Vegas chapels have made it easy for people to be as lazy as they want for the sake of convenience. Inevitably, problems occur.
FDA issued a press release today (see below), noting that the Agency is calling for safety-related labeling changes for three biopharmaceuticals used to treat certain types of anemia. The release suggests that erythropoiesis-stimulating agents (ESAs) may pose serious health risks and have questionable efficacy in alleviating symptoms of anemia and...
Well, golly, it's just great that our nation's legislators have so much faith in FDA's abilities that they keep asking the Agency to take on additional responsibilities. But consider this: isn't that kind of like a company that promotes individuals to the level of their incompetence? On Tuesday (11/6), Rep.
There are many things that scared me this Halloween: chilling warnings of unwrapped candy, the neighborhood children walking to school in their less-than-appropriate-for-the-fourth-grade costumes ( a brother and sister dressed as Britney Spears and Kevin Federline for example), and my lack of self-control involving chocolate candy bars.
More evidence of the importance of pharmacovigilance and risk assessment: A study by the U.K. Medical and Healthcare Products Regulatory Agency (MHRA) has found that the number of deaths reported in the U.K., from adverse reactions to prescription medications, more than doubled between 1996 and last year, moving from 382...
There must have been quite a party in Rockville (Md., at FDA headquarters) last Thursday evening. Earlier that day, the U.S. Senate approved the FDA Amendments Act (FDAAA) of 2007 "without debate," and news organizations were quick to enumerate the new powers the Act would bring to the Agency.
A recent article in the Archive of Internal Medicine reported on a study of medication container labels. Basically, they had prescriptions for four commonly used medications filled in six different pharmacies in four cities. Researchers then evaluated the characteristics of the format and content of the mail label and auxiliary stickers.
In 2001, a 21-year old girl, Abigail Burroughs, died of cancer after having been denied access to experimental cancer drugs which were later approved by the FDA. If Abigail had been allowed to take the drugs after all her treatment options had been exhausted, she may have survived.
GlaxoSmithkline, Sanofi-Aventis, and Wyeth feel the pharmaceutical hurt as stocks continue to drop and FDA regulations continue to tighten. Investors are also facing confusion as FDA has begun to share preliminary drug information with the general public.