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OMB to review FDA guidance

Executive Summary

The Office of Management and Budget issues a Jan. 18 bulletin to executive branch departments and agencies establishing policies and procedures for the development of significant guidance documents using FDA's guidance procedures as a model for these "good guidance practices." Each agency must designate an office to receive and address public complaints that the agency is not following procedures in the bulletin or is "improperly treating a guidance document as a binding requirement." The White House issues an executive order in conjunction with the OMB bulletin clarifying that OMB has authority to require notice and review of agency guidance documents...

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Executive order “defunded”

The House moves to block funding for Executive Order 13422, which would increase Office of Management and Budget oversight over all federal agencies, with legislation passed June 28. Among other things, the order states that OMB has the authority to require notice and review of agency guidance documents (1"The Tan Sheet" Jan. 29, 2007, In Brief). An amendment to an appropriations bill (HR 2829) passed by the House stipulates that "none of the funds made available by this act may be used to implement" the executive order. The bill provides funding for the Treasury Department, Executive Office and general government activities. The amendment was co-sponsored by Science Subcommittee on Oversight Chair Brad Miller, D-N.C., and Judiciary Subcommittee on Commercial and Administrative Law Chair Linda Sanchez, D-Cal., who each held hearings on the executive order in February (2"The Tan Sheet" March 12, 2007, p. 10). No similar action has been taken as yet in the Senate...

BioCryst’s Oral Option To Take On Injectables In HAE Prophylaxis Market

Orladeyo is the first oral prophylactic approved in the US for hereditary angioedema, with Japan and EU approvals expected to follow. Pricing of $485,000 a year undercuts segment leader.

STRENGTH Results May Weaken Chances For Omega-3 Fatty Acid Heart Health Claims

Results of Study to Assess Statin Residual Risk with Epanova in High Cardiovascular Risk Patients with Hypertriglyceridemia “should prompt reconsideration of [OTC] mixed omega-3 fatty acid products for [atherosclerotic cardiovascular disease] prevention,” say cardiologists in an editorial published with JAMA study.




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