FDA is soliciting comments on what policy topics should be developed, prioritized or implemented by the drug center’s Office of Clinical Pharmacology (OCP) to promote effective research on drug development.
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House Budget Committee Republicans are calling for an investigation into the Center for Medicare and Medicaid Innovation after a new Congressional Budget Office report highlighted mixed savings generated by accountable care organizations.
While still downplaying the potential risk to humans as testing continues after avian influenza was detected in 20% of milk sampled, administration officials Thursday (April 25) said FDA is working with industry on an appropriate regulatory pathway for rolling out vaccines made with that bulk antigen if necessary, and a vaccination prioritization plan based on responses to previous disease outbreaks is available if needed.
FDA is soliciting comments on what policy topics should be developed, prioritized or implemented by the drug center’s Office of Clinical Pharmacology (OCP) to promote effective research on drug development.
The Congressional Budget Office (CBO) is looking at expanding its evaluation of the value of diagnosis and treatment of hepatitis C beyond a 10-year budget window, as it scores a bill expanding coverage for hep C treatment.
The U.S. Patent and Trademark Office will host a May 15 webinar to discuss its guidance on using artificial intelligence tools “in practice” before the USPTO.
External stakeholders are still working to develop standards for the electronic transfer of data that providers and payers will need to comply with the No Surprises Act requirements that consumers have information about costs before receiving health care services, and CMS is exploring ways to pilot test those standards, according to a new progress report on the implementation of the NSA’s Good Faith Estimate (GFE) and (AEOB) requirements.
Medicaid beneficiary advocates and health plans are on opposite sides when it comes to the new requirements for managed care plans CMS finalized earlier this week -- while advocates call the rule’s timeliness and provider directory standards a win for beneficiaries, plans say the agency will have to work with them to address practical issues with implementation and have voiced concerns over using secret shoppers to check compliance.
HOT TOPICS
Public health groups are weighing in on FDA’s petition asking the Supreme Court to consider a circuit split over whether the agency must give individual consideration to the scientific evidence on each marketing application for a flavored e-cigarette product or can reject the applications en masse over their potential to increase youth smoking. |
New York can begin enforcing a state law passed in 2023 that restricts the sale of weight-loss and muscle-building supplements to people over 18 after a federal judge in the state denied an injunction filed by the Council for Responsible Nutrition (CRN) to delay the law from going into effect. |
Federal Trade Commission (FTC) Chair Lina Khan says capping inhaler prices and not delisting patents from the Orange Book are two separate issues and the commission will continue to scrutinize patents wrongfully listed in the Orange Book despite the industry’s moves to lower inhaler prices and plan to disclose additional information in the coming weeks. |
Congress’ Medicare pay advisors seem likely to recommend lawmakers remove the six month in-person requirement for Medicare’s behavioral health services due to commissioners’ hesitancy to uphold barriers to care amidst a shortage of mental health providers. |
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