Regulatory

Oct 01, 2006
Pharmaceutical Executive
By Pharmaceutical Executive Editors
In cases that reached a verdict between 2002 and 2006, the branded pharma industry won six of six cases by verdict in Delaware, but lost six of eight in New Jersey, all by summary judgement. Despite what judges say, it's no coincidence.
Oct 01, 2006
Pharmaceutical Executive
Scientists are worried about what they can and cannot say. Senior scientists feel that if they voice the disagreements that are important to scientific discussion, they might have to leave FDA.
Oct 01, 2006
Pharmaceutical Executive
MSLs tend to stay put. Just three in 10 left a job after less than a year. Half held their current position for more than three years.
Sep 01, 2006
Pharmaceutical Executive
The suit draws a comparison to the newspaper industry: Even though papers profit from disseminating information, the information in question isn't commercial.
Sep 01, 2006
Pharmaceutical Executive
If I ran the FDA, I'd have a Rose Garden ceremony for all the histleblowers in my agency. No one can know where all the skeletons are buried. We ought to honor every one of those patriots.
Sep 01, 2006
Pharmaceutical Executive
By Pharmaceutical Executive Editors
Indeed, at this time, we are aware of no evidence that the practice of authorized generics has actually deterred any Paragraph IV certification or post-180 day generic entry, let alone a challenge to an invalid patent.
Sep 01, 2006
Pharmaceutical Executive
Public revulsion at animal-rights extremists is damaging their cause. The majority of people deem the worst offenders to be terrorists.
Sep 01, 2006
Pharmaceutical Executive
The world according to New Hampshire: Doctors prescribe expensive drugs because pharma reps sell them. Interfere with the selling, and you'll cut down on the prescribing. It's a plan. But for what?
Dec 01, 2005
Pharmaceutical Executive
Despite heightened scrutiny from industry advocates and the beginnings of self-imposed regulation, pharma companies' violations of DTC regulations have been getting worse, says Tom Abrams, director of FDA's Division of Drug Marketing, Advertising, and Communications (DDMAC). Abrams has been on all sides of drug marketing, from receiving promotions as a pharmacist to creating promotions as a member of industry to regulating promotions as the head of DDMAC. As such, he's in good position to see the big picture.
Dec 01, 2005
Pharmaceutical Executive
FDA may be receiving fewer new drug applications for truly innovative products, but it has been overwhelmed this year with 800 abbreviated NDAs for generic drugs and thousands of supplements.
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