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Although Rep. Henry Waxman (D-Calif.) continues to support the Hatch-Waxman Act, he acknowledged last week that the law is not a complete solution to the problems generic drugmakers face in trying to bring new products to market, particularly generic biologic products.
The Centers for Medicare & Medicaid Services (CMS) officially announced the expansion of Medicare coverage for implantable cardioverter defibrillators (ICDs), as well as a proposal to expand coverage of ultrasound stimulation in certain clinical trials.
The governor of Illinois has suggested to the Canadian prime minister that the country adopt stronger rules for internet and mail-order pharmacies rather than banning prescription drug exports completely.
Modification of FDA intercenter agreements to better define roles and responsibilities for handling approvals, modifications and preapproval inspections for combination products is one of several recommendations the Combination Products Coalition (CPC) plans to submit to the agency in a draft report early next month.