Leading consumer advocacy groups say the public health stakes are high in a Freedom of Information Act (FOIA) case heard by the Supreme Court this week, warning in an amicus brief that a decision to tighten restrictions on what information can be released would virtually dry up data the groups have obtained from FDA.

A leading pediatric neurologist said he welcomed FDA’s approval of the first-ever device for treating attention-deficit/hyperactivity disorder (ADHD).

FDA issued draft guidance on Tuesday (April 23) that the agency hopes will help all FDA-regulated industries prepare for potential future voluntary recalls and work quickly when they happen.

As FDA works to develop an agricultural water rule as a part of its obligations under the Food Safety Modernization Act (FSMA), one consumer advocate said the agency could learn a thing or two from new agricultural water safety standards recently approved by the California Leafy Greens Marketing Agreement (LGMA).

Information about a drug’s effectiveness compared to alternative treatments could help drug makers argue for formulary placement in a system without rebates, Deloitte’s head of life sciences said.

Members of Congress from both parties are intervening on opposite sides of a hot-button lawsuit that will help determine whether Medicaid beneficiaries can sue their state government if the state removes certain medical providers -- such as those that perform abortions -- from the state’s Medicaid program.

CMS Administrator Seema Verma on Wednesday (April 24) invited states that aren’t currently participating in the duals demonstration to talk with the agency about starting their own version, whether through the capitated financial alignment model, the managed fee-for-service model or some other state-specific model worked out with the agency.

Siding with brand-drug makers, the Commerce Department on Wednesday (April 24) said the government should clarify that high drug prices are no basis for breaking patents.