Author Archives: Jill Wechsler

New Republican Congress to Tackle Health Reform, Biomedical Innovation, Tax Policy

The 2014 mid-term elections handed over control of the Senate to Republicans and boosted the GOP majority in the House, a clear blow to Obama administration policies, including the president’s landmark health reform initiative.  Voters were most dismayed about the economy and lack of jobs, but U.S. military snafus overseas and concerns about the Ebola […]
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"Sunshine" Policy Continues To Exempt CME Funding

A federal policy issued late last week appeared to deal a serious blow to continuing medical education (CME) programs supported by biopharma companies. But the specifics published by the Centers for Medicare and Medicaid Services (CMS) Oct. 31, 2014 actually continue to exempt independent CME funding from the Open Payments reporting requirements for transfers of […]
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Legislators Urge Added Incentives for Ebola Drug Development

Leading Senators are proposing legislation to add Ebola to the list of diseases eligible for priority review vouchers from the Food and Drug Administration as an incentive for biopharma companies to invest in treatments for this deadly disease. The priority review voucher (PRV) program for neglected tropical diseases (NTDs) currently applies to 16 deadly conditions […]
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New CDER “Super Office” to Promote Drug Quality

After almost two years of anticipation, Janet Woodcock, director of the Center for Drug Evaluation and Research, has administration approval for organizational changes to bolster programs and policies to ensure drug quality. The Department of Health and Human Services and the White House have finally signed off on her plan to establish a new CDER […]
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FDA’s New Emerging Technology Team to Assist “Innovative Manufacturers”

FDA’s Center for Drug Evaluation and Research is establishing an Emerging Technology Team (ETT) to assist innovative manufacturers in navigating the regulatory process and “overcoming roadblocks”.
Posted in Manufacturing | Leave a comment
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