Tag Archives: approvals

Orphan Drug Designation Requests and Designations Dipped in 2018, But Orphan Approvals Are Up Again!

By Kurt R. Karst — Okay, okay . . . .  It’s now a month after Rare Disease Day (on which Hyman, Phelps & McNamara, P.C.’s own Frank J. Sasinowski took part in some of the festivities).  We’re a little … Continue reading

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CVS-Aetna Merger Forthcoming Following Final Approvals

Following CVS‘s announcement in December 2017 of its intended acquisition of Aetna, the companies have received the final regulatory approvals required to merge this past Monday morning, nearly one year later, in a deal that will likely transform the healthcare … Continue reading

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Status of U.S. Biosimilar Approvals and Pending Applications*

By Kevin E. Noonan — The Biologics Price Competition and Innovation Act (BPCIA) was enacted as part of the Affordable Care Act (colloquially called "Obamacare," Public Law 111-148) (see "House Passes Health Care Reform Bill — Biosimilar Regulatory Pathway Makes … Continue reading

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EPA Approvals of TMDLs Are Not “Drive-by Permitting Determinations”

Last week, the First Circuit Court of Appeals rejected the Conservation Law Foundation’s argument that EPA’s acceptance of TMDLs in Rhode Island and Massachusetts carried with it a concomitant obligation to require permits of landowners contributing to violations of the … Continue reading

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FAA publishes new Advisory Circular for aviation fuel approvals

by Sara M. Langston with the blog faculty Source: FAA AC 20-24C Approval Propulsion Fuels and Lubricating Oils (July 29, 2011) Source: AVweb The FAA has published a new Advisory Circular providing guidance for the approval of new aeronautical fuels. … Continue reading

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