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Washington Watch

FDA WARNING Needle-Free Devices for Injection of Dermal Fillers over a photo of a woman receiving lip filler via hyaluron pe

FDA Warns on Needle-Free Injection Devices for Facial Fillers

Serious injuries and "irreversible" harm to skin, lips, and eyes reported with unapproved devices

FDA APPROVED avacopan (Tavneos) over a photo of a man鈥檚 foot showing vasculitis.

FDA Gives Thumbs Up to ANCA-Associated Vasculitis Drug

Approval granted to avacopan despite advisory committee concerns

A photo of the Medtronic 670G insulin pump

Back-to-Back Recalls for Medtronic Insulin Pumps

Class I recalls on 600 series pumps and 500 series remotes

A female physician discusses a hip replacement with her senior female patient.

Medicare Is Sticking With Mandatory Demonstration Models for Now

But "we need to move away from having a model for every episode," says CMMI head Elizabeth Fowler

A radiating zig zag pattern over a photo of the U.S. Embassy in Havana, Cuba.

'Havana Syndrome': A Real and Present Danger

A breakdown of the who, what, when, why, and how

The cover art for this Anthony Fauci documentary.

New Fauci Documentary: 'You Don't Get Intimidated'

Anthony Fauci gets personal in new film, opens up about Trump admin and history repeating

FDA APPROVED Siemens Naeotom Alpha over an image of a senior man in a CT scanner.

FDA Clears 'Major Advancement' in CT Imaging

New Siemens' CT scanner is first allowed by agency with photon-counting detectors

Two bags of blood platelets.

The Cost of Blood Platelets Is About to Surge

FDA's flawed new guidance for blood transfusion safety takes effect October 1

Two computer rendered cigarette packs with graphic warning labels.

How Many Deaths Will New Cigarette Warnings Prevent?

Modeling study comes up with big numbers

A vial of the Moderna COVID-19 vaccine on an orange and a vial of the Pfizer-BioNTech COVID-19 vaccine on an apple.

I Got Moderna. Can I Boost With Pfizer?

"There's all sorts of anarchy going on"

A pregnant physician looks at MRI images on a tablet in her office

COVID Vax Exemptions for Pregnant Healthcare Workers?

Hospital policymakers are juggling staffing shortages, conflicting laws, and CDC guidelines

An out of focus male physician, hand on his chin, thinking in front of his laptop.

'Privacy Exception' No Cure for Doctors' Open Notes Headaches

Provision is "unworkable," harms patients, and adds to clinical stress, doctors say

FDA APPROVED Ruxolitinib (Opzelura) over a photo of atopic dermatitis on a man鈥檚 arm

FDA Approves First Topical JAK Inhibitor for Atopic Dermatitis

Significant skin clearance, reduced itch in majority of patients treated with ruxolitinib cream

The Supplement Facts from a phenibut supplemental product.

Unapproved Drug Found in Dietary Supplements Despite FDA Warning

Phenibut was found in all four products analyzed, with increased quantities in three

FDA RECALL Medtronic Pipeline Flex + Pipeline Flex with Shield Technology over a computer rendering of the device.

Pipeline Flex Endovascular Flow Diverters Under Recall

Serious injury and death linked to fracturing issue in the delivery system, FDA warns

Two white rubber gloved hands pour yellow and blue liquids from beakers into another vessel.

The Technological Marvel of Combination Vaccines

Many questions remain for co-formulating COVID vaccines, but pursuing this now is the right move

A hissing snake coiled in the shape of a uterus on a rough map of the state of Texas.

HHS Announces Actions in Response to Texas Law Banning Abortions After 6 Weeks

Agency increases family planning funds, reminds providers of need to treat medical emergencies

A syringe and seven vials of Comirnaty COVID-19 vaccine.

Pfizer Makes Its Case for COVID Booster Shots

Ahead of advisory meeting, FDA staff notes "inferred" effectiveness, and no new safety concerns

A computer rendering of an inflamed shoulder joint next to a syringe drawing from a vial.

Doctors Work to Treat, Understand Post-Vaccine Shoulder Injury

SIRVA is mainly in the medicolegal realm, but physicians acknowledge its rare possibility

A view of the tribute in light in Manhattan during the anniversary of 9/11.

Cough, Cancer, PTSD: Two Decades of World Trade Center Studies

Research has revealed the fallout of response to a crisis

A prescription medication bottle lying on its side filled with $100 bills.

PhRMA Warns of Dire Consequences if Medicare Allowed to Negotiate Drug Prices

"We know how the story ends" when the government sets prices, group says

FDA ADCOMM AAV Gene Therapies over a computer rendering of neurons.

Gene Therapies Require Neurologic Monitoring

Nerve conduction, MRI monitoring may mitigate neurotoxicity risks

FDA ADCOMM AAV Gene Therapies over a computer rendering of the liver anatomy.

Liver Toxicity in Gene Therapy Trials Could Merit Stricter Entry Criteria

FDA panel weighs in on lower vector doses and role of animal studies

Kristina Christensen, RN.

'Forced to Lie': Med Titration Standards Put Critical Care Nurses on Shaky Ground

Survey finds nurses feeling "moral distress" at "profoundly unrealistic" standards

COVID-19 vaccination record card with syringe and vial.

Take Another Look at the Spacing Between COVID Vaccine Doses

Growing body of research suggests robust immune response with extended dosing interval

An image of of package of Xeljanz

FDA Slaps Restrictions on JAK Inhibitors Over Serious Safety Risks

Use for inflammatory conditions limited to those who fail on TNF blockers

Explanation of benefits paperwork.

Doc Groups Hail Decision to Delay 'Advanced EOB' Rule

Regulation set to start on January 1, but administration says it will "defer enforcement"

FDA APPROVED MicroTransponder Vivistim Paired VNS System (Vivistim System) over a photo and computer rendering of the device

Novel Stroke Rehab Treatment Wins FDA Approval

Neurostim system approved for upper limb deficits

The packaging and blister pack of Ivermectin tablets USP 6mg.

Ivermectin Scripts, Poison Center Calls Boom During Delta Surge

CDC warns healthcare providers to steer patients away from the controversial drug

FDA WARNING Eco-Med Ultrasound Gels and Lotions over a photo of a bottle of EcoGel 200 ultrasound gel.

FDA Warns on Contamination Risk With Eco-Med Ultrasound Gels

Healthcare providers must toss all of company's gels and lotions, agency says

FDA APPROVED over a computer rendering of a tumor.

FDA Grants Tissue-Agnostic Approval to Dostarlimab for dMMR Tumors

Overall response rate of 41.6% in various tumor types with mismatch repair deficiency

FDA APPROVED calcium, magnesium, potassium, and sodium oxybates (Xywav) over a photo of a young woman asleep at her computer.

First Drug OK'd for Idiopathic Hypersomnia

Sleep drug Xywav gains a new indication

HIMSS over a conceptual image of a physician accessing data via a tablet.

Notice Any Rule Changes in Washington? You Can Thank COVID

"It's opened a Pandora's box, which is not going back"

A photo of radiotherapy equipment

Medicare's Radiation Oncology Payment Model Vexes Oncology Community

Participation required for certain radiation oncology practices starting next January

A map of the world created by the arrangement of various pills and capsules.

CMS Proposes to Rescind 'Most Favored Nation' Drug Pricing Rule

Regulation from Trump administration had been barred from taking effect due to court challenges

A Juul vape pen and packaging and pack of Virginia tobacco flavored pods.

All Eyes on FDA: The Upcoming Regulation of Juul E-Cigarettes

Will the public health be protected?

A man in a business suit knocks on a door with a placard that reads: Office of Climate Change and Health Equity.

HHS's Climate Change Office: Not Open Yet, but Getting Positive Reviews

Initial steps "highly encouraging," says one expert

FDA ADCOMM TriGuard 3 cerebral protection device over a computer rendering of the device.

TAVR Debris Deflector Doesn't Fly With FDA Advisory Panel

TriGuard 3 met with skepticism in its bid for approval

A series of images depicting the journey from substance abuse to completion of treatment.

Lawyers Advertise to Nurses: Think Twice About State Rehab Programs

Attorneys charge that programs can be aggressive, costly, and not in the nurse's favor

A Department of Veterans Affairs placard on the building exterior in Washington DC.

AMA, Physician Groups Slam VA's Planned Standards of Practice Changes

Lack of transparency criticized

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