FDA on Tuesday (May 24) announced United Kingdom-based infant formula maker Kendal Nutricare will import around 2 million cans of formula into the United States while U.S.-based formula maker Abbott Nutrition will release about 300,000 cans of specialty formula from its Sturgis, MI, facility, all of which will lead to millions of cans of additional infant and specialty formula being available in the United States in the coming months, the agency says.
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HCBS Providers Must Comply With Settings Regs Despite Workforce Crises
CMS says it expects states and home and community-based services providers to come into compliance with regulations as set out in its Home and Community-Based Services Final Rule Update on Tuesday (May 24), and the agency does not make exceptions for states, residential facilities or other care settings that have struggled to stay afloat amid rampant workforce shortages.
Latest Pandemic News
FDA Panel Will Meet June 15 To Discuss COVID Shots For Kids Under 5
FDA’s vaccine advisers are expected to meet June 15 to discuss Pfizer’s and Moderna’s COVID-19 vaccines for kids ages 6 months to 4 years and 6 months to 5 years, respectively, the agency announced Monday (May 23).
FDA Will Assess Data On T-Cell Levels Produced By COVID-19 Vaccines
CMS Launches Medicaid, CHIP Renewal Webpage For Beneficiaries
Latest News
CMS says that while publicly available data on COVID-19 vaccine booster levels for nursing home staff and residents is not part of quality ratings for the sector, the agency is focused on making sure beneficiaries and their families are aware of vaccination rates.
FDA recently declined to ban certain phthalates -- chemicals that are used to make plastics flexible -- from being used in food packaging and food production equipment, a move that health advocacy and environmental groups, including the Environmental Defense Fund, Center for Food Safety and Center for Science in the Public Interest, say will have detrimental health effects on women, children and other vulnerable populations for years to come.
Surgeon General Vivek Murthy’s new advisory on burnout in the health care workforce calls for an all-hands effort to protect and support health care workers as the sector scrambles to reduce providers’ retirements and resignations in the face of a looming vacancy crisis.
Evidence is increasing that cases of acute hepatitis of unknown origin in young children are linked to adenovirus, Centers for Disease Control and Prevention officials told reporters in a briefing on Friday (May 20).
FDA on Thursday (May 19) approved an intravenous version of SIGA Technologies’ smallpox drug TPOXX (tecovirimat), coming as cases of monkeypox -- which is in the same viral family as smallpox -- emerge around the world and in the United States.
FDA on Friday (May 20) announced its Enterprise Modernization Action Plan (EMAP) through which the agency hopes to develop a more standard, agency-wide -- rather than siloed and fragmented -- approach to data management and business processes.
Most stakeholders expect HHS will renew the public health emergency declaration in mid-July for 90 days with some speculating about the possibility of another extension to carry pass the midterm elections, but experts say the administration could renew the declaration for fewer days if it wanted to and still fulfill its promise to provide stakeholders with 60-days advance notice.
There are certain policies states can adopt now -- ex parte redeterminations and letting people renew online or over the phone -- to avoid making the 16 million Medicaid and CHIP beneficiaries predicted to lose their coverage a reality once the public health emergency ends, Center on Budget and Policy Priorities experts say.
Draft SCOTUS Opinion Creates Firestorm
Mifepristone Could Be Dispensed On Federal Land In Abortion-Ban States
If Roe is overturned, multiple states are expected to outlaw abortion, but legal scholars say FDA regulation of the abortion pill, mifepristone, could preempt state laws and allow mifepristone to be prescribed and dispensed on federal land, even in states that ban abortion.
Roe Reversal Would Prove Disastrous For Workforce, Experts Say
Abortion Providers Irate Over Oklahoma ‘Bounty-Hunter’ Abortion Ban
Roe Reversal Could Cut Off Miscarriage Training For Nearly Half Of Residents
Dems Press CMS To Ensure Medicaid Provider Choice As States Ban Abortion
Focus On MA
AHA To CMS: Stop MA Denials, Rework Prior Authorization
The American Hospital Association wants to meet with CMS to discuss ways to hold Medicare Advantage Plans accountable for what it alleges are inappropriate and illegal restrictions on beneficiary access due to prior authorization and other policies, and it says the HHS Office of Inspector General’s recent MA recommendations don’t go far enough.
AHA Asks DOJ To Set Up Medicare Advantage Fraud Task Force
Cavanaugh Worries ‘Non-Productive’ Companies Use MA Diagnoses For Profit
FDA User Fee News
E&C Clears User Fee Bill, Leaves Door Open For LDT, Cosmetics Measures
The House Energy & Commerce Committee on Wednesday (May 18) passed 55-0 comprehensive user fee legislation that includes new language giving FDA authority to require sponsors of pediatric cancer trials to study a combination of drugs, rather than one drug at a time, in order to speed development of drugs that treat relapsed cancer.
Senate User Fee Bill Includes Measures To Reform LDT Regulation
Senate User Fee Bill Would Boost FDA’s Oversight Of Cosmetics
Senate User Fee Bill Mandates Supplements Makers Send Info To FDA
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