The FDA Law Blog

OCTOBER 18, 2022

On October 17, 2022, FDA published the list of CDRH proposed guidances for FY 2023 (see here ). These are documents on the A-list, a list of prioritized documents that FDA intends to publish during FY2023. FDA published draft guidances for these topics in December 2021 ( here and here ).

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The Checkup by Singlecare

APRIL 17, 2024

Mounjaro (tirzepatide) is an injectable medication prescribed for Type 2 diabetes mellitus, which some doctors may prescribe off-label for weight loss. Legislation passed in 2003 prohibits Medicare from covering drugs prescribed specifically for weight loss, and while Medicaid has more flexibility here, not every state will cover them.

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The Checkup by Singlecare

MARCH 7, 2024

Yet the Food and Drug Administration (FDA) hasn’t approved this GLP-1 agonist injection for weight loss. Instead, it’s FDA approved to improve glycemic control in adults with Type 2 diabetes and to reduce the risk of adverse cardiovascular events in adults with Type 2 diabetes and known heart disease.

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European Pharmaceutical Review

OCTOBER 19, 2023

we must prove the effectiveness of radiopharmaceuticals through clinical trials… This has been demonstrated recently with PLUVICTO… the first US Food and Drug Administration (FDA)-approved targeted radioligand therapy for eligible patients with prostate cancer” At this moment, there is no single treatment for cancer today.

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pharmaphorum

OCTOBER 27, 2021

This year has been marked by one of the biggest developments in the search for new treatments for Alzheimer’s disease, after the US FDA approval of Biogen’s Aduhelm (aducanumab) in June. The monoclonal antibody was the first new drug to be approved for Alzheimer’s since 2003. The challenge of treating Alzheimer’s.

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PharmaShots

APRIL 20, 2023

Food and Drug Administration (FDA) in June 2020 as a rapid-acting insulin to improve glycemic control in adults with type 1 and type 2 diabetes. On October 14, 2022, the FDA approved Lyumjev® (insulin lispro-aabc injection), a rapid-acting mealtime insulin, for the treatment of children with diabetes.

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The Checkup by Singlecare

FEBRUARY 6, 2024

Food and Drug Administration (FDA). This drug stands out as one of the few non-stimulant options for the treatment of adults and children with attention-deficit hyperactivity disorder ( ADHD ) that are approved by the U.S.

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European Pharmaceutical Review

SEPTEMBER 22, 2023

Limitations of monoclonal antibody therapies Regulatory approvals from the US Food and Drug Administration (FDA) for aducanumab and lecanemab – and likely very soon for donanemab also – opened a route for different therapeutic modalities and other relevant disease targets, such as tau. Landry I, Kanekiyo M, Aluri J, et al.

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The Checkup by Singlecare

AUGUST 5, 2023

Cialis was initially approved in 2003 and has become a popular alternative to Viagra (sildenafil). Erectile Dysfunction Cialis is FDA-approved for ED and BPH. Benign Prostatic Hyperplasia Another FDA-approved use of Cialis is the treatment of BPH , which is characterized by an enlarged prostate.

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The Checkup by Singlecare

DECEMBER 6, 2023

Alcohol and propylene glycol-containing products Similar to concurrent use of alcohol, concurrent use of propylene glycol with metronidazole or within three days after completing metronidazole is considered a contraindication in FDA metronidazole prescribing information.

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ISPE

MAY 10, 2023

5 (2003): 395–413. 3M explores New Label-As-A-Service Concept with Blockchain on Azure to Stop Counterfeit Pharmaceuticals.” SPuMoNI is particularly timely because blockchain has been proposed to become “a new digital service infrastructure” for Europe. van Dorp, and J. Managing Traceability Information in Manufacture.” Microsoft.com.

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The Checkup by Singlecare

JANUARY 18, 2024

Food and Drug Administration (FDA) to treat congestive heart failure and hypertension. Carvedilol is also used off-label for multiple other indications, like angina or chest pain, atrial fibrillation , early treatment and secondary prevention of heart attacks, left ventricular dysfunction, and ventricular tachycardias.

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The Checkup by Singlecare

AUGUST 3, 2023

American Public Health Association, 2015) Weight loss and overall health The Food and Drug Administration (FDA) estimates that around 70% of adults in the U.S. FDA, 2021) (WHO, n.d.) Annals of Internal Medicine, 2003) Physical activity can reduce the risk of cancers, including breast , colon , kidney, and bladder. have obesity.

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The Thyroid Pharmacist

JULY 20, 2023

Just this year, the FDA approved Jesduvroq tablets (daprodustat) as the first oral treatment for anemia caused by chronic kidney disease, for adults who have been receiving dialysis for at least four months. [58] A reinvestigation using Fe-labelling and non-invasive liver iron quantification. 1989;114(4 Pt 1):657-663. Int J Sports Med.

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