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).
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FTC Extends Warning Letters Over 'Junk' Patents To Ozempic And Other Drugs
The Federal Trade Commission (FTC) sent a second wave of warning letters to 10 additional companies for submitting what it deems “junk” patent listings in FDA’s Orange Book, including patents for Novo Nordisk’s blockbuster drug Ozempic and other drugs for diabetes, weight loss, asthma and chronic obstructive pulmonary disease (COPD).
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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
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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 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.
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