Cardiology

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FDA releases plan to expedite, promote generic drug development

June 27, 2017

As part of its effort to increase competition in the prescription drug market, the FDA released a list of drugs that are off-patent and off-exclusivity without approved generics and produced a revised manual of policies and procedures for review of abbreviated new drug applications, including prioritization for generic products.

“No patient should be priced out of the medicines they need, and as an agency dedicated to promoting public health, we must do our part to help patients get access to the treatments they require,” Scott Gottlieb, MD, commissioner of the FDA, said in an agency press release. “Getting safe and effective generic products to market in an efficient way, being risk-based in our own work and making sure our rules aren’t used to create obstacles to new competition can all help make sure that patients have access to more lower-cost options.”

Armed with CBO report, AAFP sharply critical of Senate health care bill

June 27, 2017
AAFP has unleashed a new round of criticism in the wake of the Congressional Budget Office releasing an analysis of the Senate health care bill known as the Better Care…

REVEAL: Anacetrapib plus atorvastatin reduces coronary events in high-risk patients

June 27, 2017
Merck announced anacetrapib, its investigational cholesteryl ester transfer protein inhibitor, significantly reduced major coronary events vs. placebo when added to…
In the Journals

ITALIC: Results for 6-month, 24-month DAPT similar 2 years after DES implantation

June 27, 2017
Patients who received 6-month dual antiplatelet therapy after PCI with a second-generation drug-eluting stent have similar outcomes to patients who received dual…
In the Journals

Platelet reactivity not linked to clinical outcomes after PCI in patients with PAD

June 27, 2017
Peripheral artery disease was linked to an increased risk for adverse events after PCI with a drug-eluting stent, but this association was not directly affected by high…
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