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M. Nielsen Hobbs

M. Nielsen Hobbs has more than 20 years of experience covering the pharmaceutical industry, and writes frequently about the intersection of business, regulation, science and politics. Before joining the “The Pink Sheet” he worked for Congressional Quarterly. Hobbs enjoys discussing BB-8 almost as much as he enjoys talking about 351(k).
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Latest From M. Nielsen Hobbs

Orphan Drug Tax Credit Defense Adds To NORD's Legislative Challenges

Republican tax reform proposal would eliminate research credit; NORD already had its hands full countering 'misinformation' about impact of orphan drugs on drug spend; critics on Capitol Hill argue sponsors are gaming the system.

Rare Diseases Legislation

Orphan Pediatric Loophole To Be Closed By US FDA

Commissioner Gottlieb hopes accomplish through guidance a policy change that advocates failed to get included in user fee legislation passed earlier this year.

Rare Diseases Legislation

Policy Prescriptions: User Fees, Biosimilars, Brexit

US FDA extends its own user fee deadline; biosimilars earn a dubious milestone; and EMA unveils some contingency planning for Brexit. Policy Prescriptions rounds up recent regulatory news and trends reported by sister publication the Pink Sheet

FDA Advisory Committees

House-Senate Versions Married In Latest User-Fee Bill, Up For July 12 House Debate

Differences between Senate and House Committee versions of the FDA Reauthorization Act passed in May and June to approve five-year device user-fee agreements have been smoothed over by committee staff and joined together in the latest version of the act. The bill has been placed on the House's calendar in anticipation of July 12 action to debate and approve the bill. Next steps in the Senate, meanwhile, remain to be seen.

Policy Legislation

User Fee Reauthorization: 'Pre-Conferenced' Bill Aims For Quick Passage

'Clean' bill includes expanded access language from Senate, generic review revisions from House as legislators hope for enactment this month.

Legislation FDA

Generic Program Is Biggest Extra Item In Senate User Fee Reauthorization Bill

US FDA would need additional appropriations to cover all activities contemplated in the legislation – and the bill appears to need a pay-for because it increases the deficit.

Generic Drugs Legislation
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