Tag Archives: FDA

Big Wins, a Cliff, a Race and a Red Face: A 2012 Recap

Now that 2012 is drawing to a close, it’s once again time to take a look back at a year that saw some big hits and misses for the biotech industry – and there were plenty of both. The hits…

Share

FDA’s Confusing Action Against Burzynski – What Does it Really Mean?

Last month the FDA’s Office of Prescription Drug Promotion (OPDP) issued a warning letter to the Burzynski Research Institute Inc. and the Burzynski Clinic regarding claims made for its antineoplastons A10 and AS2-1 injections that violate the Federal Food, Drug,…

Share

Caught in Its Own Snare

A hunter walks into a bar and says, “Did you hear the one about the FDA?” “You mean the time it shot itself in the foot?” the bartender responds. “The left foot or the right foot?” another hunter asks, wiping…

Share

BIO-Buzzwords Won’t Die, So We May as Well Evolve Them

For BIO 2011, BioWorld published a list of overused BioCliches to shun, and I was pleased to observe that attendees and speakers must’ve taken notice and avoided using them at BIO 2012 this year. However, since the urge to use…

Share

A Nightmare on BIO 2012 Exhibition Street

BOSTON ‑ After crisscrossing the exhibition hall and three Boston zip codes yesterday for my citywide BIO 2012 reception scavenger hunt and finding a belly full of German sausages, Chinese dim sum, French pastries, Japanese sake and Irish whiskey to…

Share

Biotech Falls For April Fools’ Prank – Again!

The contenders for becoming the April Fool in Life Sciences for 2012 came down to three candidates, but two of them have persisted past the April 1 deadline, thereby removing themselves from consideration. President Barack Obama still has a glimmer…

Share

Conference Etiquette – is There an App for That?

There’s a new contagious condition circulating that has even infected the biotech sector: e-Distraction, with bad manner side effects of indecorum, insensitivity and more. The wealthy are often regarded as egocentric and out of touch with reality by the 99…

Share

The Death of ‘Innocent Until Proven Guilty’?

Unlike every other country in the world at the time, the U.S. founded its judicial system on the premise “innocent until proven guilty.” Under that guiding principle, the burden of proof – in any enforcement action – lies with the…

Share

The FDA: Stuck in 1984

While 2012 has dawned everywhere else in the world, it’s still 1984 at the FDA. With its Bad Ad program, whistle-blower suits and spotters of conference crimespeak serving as its globalwise eyes and ears, the agency has adopted Big Brother…

Share

The Good, the Bad and . . . the Huh? A 2011 Biotech Recap

The past year brought the biotech sector a mixed bag of news. Some of it was positive – for instance, the FDA picked up its drug approval pace in 2011 and, in some cases, even surprised the most hardened biotech…

Share