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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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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House Energy & Commerce Committee members scuffled over a new home and community-based services rule that sets a baseline for Medicaid payments to direct care workers -- and the impact the rule will have on access to care -- during a committee hearing Tuesday (April 30).
FDA plans to hold a listening session in June to discuss possible changes to the role of its advisory committees, coming as senior agency officials seek to shift the advisers’ focus on product approval decisions to debates surrounding scientific policies.
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