FDA Releases Draft Guidance On Determining What Constitutes a “Qualified Facility” Under FSMA Preventive Controls Rules

On Friday, the FDA announced the availability of a draft guidance describing its current thinking on how to determine whether a business is a “qualified facility” that is subject to modified requirements under its previously released rules governing current good manufacturing practice, hazard analysis and risk-based preventive controls for human food and animal food (“the Preventive Controls Rules”).

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A District Court Just Dealt a Blow to the ACA. Employers, Don’t Get Excited!

By | Benefits Law Advisor | May 13, 2016
A District Court Just Dealt a Blow to the ACA. Employers, Don’t Get Excited!

On May 12, 2016, the United States District Court for the District of Columbia issued an opinion in U.S. House of Representatives v. Burwell et al., No. 14-1967 (D.D.C. May 12, 2016), enjoining the federal government’s use of unappropriated monies to fund reimbursements to health insurers under Section 1402 of the Patient Protection and Affordable Care Act (the “ACA”). 

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FTC Granted 2-Week Reprieve in Effort to Block Pennsylvania Hospital Merger

The Federal Trade Commission (“FTC”) and the state of Pennsylvania have two weeks to persuade the Court of Appeals for the Third Circuit that the pending merger of Penn State Hershey Medical Center (“Hershey”) and Pinnacle Health System (“Pinnacle”) is anticompetitive. 

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