Regulatory

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.
Dec 01, 2005
Pharmaceutical Executive
By Pharmaceutical Executive Editors
The public is focused on drug safety, but the real issue isn't approval standards. It's the way drugs expand to unapproved new indications. Are you listening, Acomplia?
Nov 01, 2005
Pharmaceutical Executive
Medicare's Competitive Acquisition Program takes a shot at reforming Part B drug distribution. But the new rules evoke a vast and complicated Rube Goldberg machine, where nobody gains much—except CMS.
Nov 01, 2005
Pharmaceutical Executive
Under one bill, states could license patented drugs to generics companies, paying patent holders a royalty.
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