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Cuban: More Deals In Works To Make Pediatric Cancer, Other Drugs In Shortage

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).

LDT News

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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OCR Finalizes Rules Barring Discrimination Based On Disability, Clarifies Grantees Must Comply With Bostock

The Biden administration this week finalized two non-discrimination rules, including one that ensures programs that get HHS funding do not discriminate against people with disabilities, which HHS touts as the most significant update to the rules preventing such discrimination in more than 50 years.

NC Judge Rules Only Some State Mifepristone Restrictions Preempted By FDA

Abortion advocates, and FDA’s authority as a federal agency, received a partial victory in North Carolina court this week, with a district judge ruling that some restrictions the state sought to impose on the abortion drug mifepristone are preempted by FDA’s congressional mandate.

CMS Official: CMS Will Soon Give States Deadlines To Update Medicaid Enrollment Systems

CMS will soon lay out specific deadlines for states to update their Medicaid eligibility and enrollment systems amid concerns that slow state implementation is causing individuals to prematurely lose coverage, a CMS official told House lawmakers this week.

Dems Aim To Change FDA Approach To Cannabis As Rescheduling Proceeds

As the Biden administration takes steps to move marijuana to a less-restrictive drug “schedule” allowing for more use in medical contexts, prominent Senate Democrats have reintroduced a bill that would create a new regulatory pathway at FDA and a Center of Cannabis Products.