Posts Tagged "FDA"

, Abbott gets nailed for off-label promotion

Abbott gets nailed for off-label promotion

Abbott got nailed for its off-label promotion of drug Depakote this May.  The $1.5B settlement covers civil, criminal, and administrative charges, but the settlement still leaves the door open for prosecutors to come after Abbott management...

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, REDUCED MEDICARE REGULATORY BURDENS ON HEALTH CARE PROVIDERS WILL SAVE OVER $5 BILLION

REDUCED MEDICARE REGULATORY BURDENS ON HEALTH CARE PROVIDERS WILL SAVE OVER $5 BILLION

Press Release- May 10, 2012, the Centers for Medicare & Medicaid Services (CMS) finalized two rules today to reduce unnecessary, obsolete, and/or burdensome regulations on American hospitals and health care providers.  These rules will...

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, FDA and HHS refuse to implement Section 6004 of the Affordabale Care Act

FDA and HHS refuse to implement Section 6004 of the Affordabale Care Act

Section 6004 of the Affordable Care Act requires manufacturers and authorized distributors of record to submit very specific information on recipients of free drug samples to FDA annually beginning April 1, 2012.  FDA issued draft guidance announcing that it...

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, FDA’s early feasibility study IDE applications

FDA’s early feasibility study IDE applications

FDA has announced new draft guidance for early feasibility study IDE applications, a completely new clinical approval mechanism for FDA.

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