Per a U.S. district court order, FDA has pushed back the date by which all cigarette packages and advertisements must bear new textual warning label statements and color graphics that depict the negative health consequences of smoking.
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Coronavirus Response
Regulatory Experts: Up-To-Date COVID-19 Data From CDC Could Help FDA
Regulatory lawyers agree with former FDA chief Scott Gottlieb’s calls for the Centers for Disease Control and Prevention to release up-to-date information about COVID-19.
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Public Citizen: Don’t Rely On Insurers’ Whim For Cost-Free Treatment
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BCBSA, Anthem Extend Cost-Free Treatment Through Health Emergency
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W&M Looks At Reducing COVID-19 Disparities Through Medicaid
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FDA Forewarns Of User Fee Goal Delays As It Focuses On COVID-19 Drugs
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FDA, Industry Ponder Future Of Remote Clinical Trial Visits, Monitoring
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A group of Democratic senators, led by health committee ranking Democrat Patty Murray (WA), say FDA should make public a list of marketed e-cigarettes and other deemed tobacco products for which the agency receives premarket applications by Sept. 9, the deadline by which all deemed products must submit premarket tobacco applications and substantial equivalence reports.
FDA and the U.S. Department of Agriculture have informally agreed that FDA will assume sole responsibility for regulating cell-based seafood other than catfish as part of an evolving pact on oversight of the nascent cell-based food industry.
Rep. Buddy Carter (R-GA) introduced a bill to give a 30% tax credit to makers of drugs, protective medical gear and diagnostics that are manufactured in the United States, and Sen. Tim Scott (R-SC) is trying to drum up support for a sister bill.
Part D plans may waive costs for drugs that treat COVID-19, even if those waivers are inconsistent with the bid and plan benefit package, according to a May 22 update to Medicare coronavirus guidance.
A new agreement between FDA and the U.S. Department of Agriculture solidifies USDA’s authority to invoke the Defense Production Act to force food harvesting, processing and manufacturing facilities, including plants typically regulated by FDA, to remain open during COVID-19, one food industry lawyer told Inside Health Policy.
The Trump administration unveiled a national strategic COVID-19 testing plan, as required by CARES Act, on Sunday (May 24), which Democrats were quick to criticize as putting too much responsibility on states to expand testing.
The House Ways & Means Committee will hold a virtual hearing on the disproportionate impact of COVID-19 on communities of color shortly after the Centers for Disease Control and Prevention released a short report on the issue that was panned by key Democrats.
Medicare beneficiaries in all states, the District of Columbia and Puerto Rico are expected to able to buy insurance that caps monthly insulin premiums at $35, for an average annual savings of $446 for the approximate 1.3 million beneficiaries who could benefit from the demo, CMS said Tuesday (May 26).
State insurance regulators should ensure carriers are able to update any 2021 provisional rates to include new information on COVID-19, and a neutral panel of experts should create guidance on how to handle those costs, health care experts say in a recent blog post on the rate review process.
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