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Cuban: More Deals In Works To Make Pediatric Cancer, Other Drugs In Shortage

Mark Cuban, founder of the Mark Cuban Cost Plus Drug Company, tells Inside Health Policy he has more deals in the works to produce pediatric cancer and other drugs in shortages for hospitals, after having inked an initial agreement with Community Health Systems (CHS).

LDT News

FDA Guide Lays Out LDT Enforcement Discretion For Public Health Threats

In light of its new rule asserting regulatory authority over laboratory-developed tests, FDA will continue to exercise enforcement discretion for some tests during public health emergencies (PHEs) and for emergent public health threats, the agency says, depending on public health needs, especially if unauthorized tests are the only options available to diagnose an emerging disease.

FDA Adds Significant Enforcement Discretion ‘Carve Outs’ In Final LDT Rule

Latest News

Advocacy Groups Bash Work Requirements In MS Medicaid Expansion

Mississippi lawmakers are expected to vote this week on a deal to expand Medicaid per the Affordable Care Act, but, in a last-minute move blasted by advocates, hinge the expansion on CMS approval of work requirements for obtaining those benefits.

HHS, FTC Extend RFI Period On Private Equity Health Impacts

HHS, the Federal Trade Commission (FTC) and the Department of Justice’s Antirust Division are extending the deadline for a request for information seeking public comment on how private equity and corporate ownership is impacting the quality of health care.

FDA: Lack Of Funding Will Impact Staffing Levels, Inspections

The ability to hire more staff for inspections will be affected if FDA is not granted the funding it needs from Congress, Associate Commissioner Michael Rogers of FDA’s Office of Regulatory Affairs said at an Alliance for a Stronger FDA webinar May 1.

House GOP Challenges White House Over Debt Law Waivers Used In Home Health Rule

House Budget Committee Republicans are questioning the Biden administration's interpretation of a 2023 debt limit law provision that permits exemptions from proposed budget-balancing measures for certain regulatory actions.