FDA Law Blog: Biosimilars

DECEMBER 3, 2023

As part of this change, the Coverage Gap Discount Program (CGDP), a program that has existed since 2011, will sunset on December 31, 2024, and be replaced by the Medicare Part D Manufacturer Discount Program (the “Discount Program”). Kirschenbaum — The Inflation Reduction Act (IRA) significantly changed the Part D benefit.

Labelling 105

Labelling Drug Pricing Compounding Payment Processing 105

The Thyroid Pharmacist

MARCH 7, 2025

to fluoride in my tap water, to hidden mold in my home, to my shampoo and deodorant (have you ever read those labels?!), 16] Even more concerning, of the 133 different VOCs found across all tested products, only one, ethanol, was actually listed on any label! From indoor pollutants like formaldehyde (yes, really!),

Health and Personal Care Stores 66

Health and Personal Care Stores Labelling Immunity Immunization 66

The Thyroid Pharmacist

DECEMBER 7, 2022

Several years ago, after reading research about all of the toxins commonly used in flame retardants (and learning about all of the many products in my home that contain these chemicals… somewhat of a shocking list), I looked at my mattress label, only to learn it contained one of the chief offenders. Labels (Furniture, Fabrics, and Carpet).

Health and Personal Care Stores 88

Health and Personal Care Stores Labelling Immunity Immunization 88

The Thyroid Pharmacist

JULY 29, 2022

I’ve seen a number of airborne toxins showing up as frequent triggers/exacerbating factors for my clients’ autoimmune conditions — mold, volatile organic compounds (VOCs), and artificial/synthetic fragrances, in particular. For sunscreens and other over-the-counter drugs, fragrances must be identified on the label.

Health and Personal Care Stores 52

Health and Personal Care Stores Compounding Immunity Immunization 52

The Thyroid Pharmacist

SEPTEMBER 1, 2023

The fluorine anion (negatively charged ion), or any of the compounds containing the anion, are termed fluorides. The fluoride in drinking water comes from the addition of a fluorine compound (usually sodium fluoride, sodium fluorosilicate, or fluorosilicic acid), which dissociates to release the F- ion.

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Adverse Reactions Compounding Chemotherapy Labelling 116

The Thyroid Pharmacist

JANUARY 6, 2023

It breaks my heart to think about the many thyroid patients who get labeled as clinically depressed instead of being tested for thyroid antibodies, and to think of the patients who start on thyroid hormones without consideration of dosage and form, resulting in ongoing symptoms, including depression.

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Dosage Labelling Communication Compounding 122

The Thyroid Pharmacist

JULY 7, 2023

In a study done in 2010, NAC and 15-Deoxy-Prostaglandin J2 (a fatty acid compound with antioxidant and anti-inflammatory properties) exerted a protective effect against autoimmune thyroid destruction in vivo. [47] 2011-0228 [2] Müssig K, Künle A, Säuberlich AL, et al. 2011-3350 [19] Eschler DC, Hasham A, Tomer Y. doi:10.1210/jc.2011-0228

Immunity 105

Immunity Immunization Diabetes Dosage 105

The Thyroid Pharmacist

JULY 20, 2023

There are various iron salts, or compounds, and each of them have different levels of elemental iron in them. [63] 79] In a 2011 study, 119 women that had a riboflavin deficiency were given either 2 g or 4 g of riboflavin, or a placebo for eight weeks. [80] 2011 Dec;57(4):369-77. [28] Published 2021 Jan 14. 2020;19(1):32-36.;

Health and Personal Care Stores 98

Health and Personal Care Stores HIV Treatment and Prevention Agents Immunity Immunization 98

The Thyroid Pharmacist

JANUARY 20, 2023

Please consider the following and be sure to read the precautions on individual labels before you try a new herb, supplement, or blend. (In Some individuals may be sensitive to anthraquinone compounds, which are present in aloe latex (taken from the outer skin of the plant) and aloe whole leaf extracts. 2011 May;20(3):225-39. [11]

HIV Treatment and Prevention Agents 98

HIV Treatment and Prevention Agents Diabetes Immunity Immunization 98

The Thyroid Pharmacist

NOVEMBER 15, 2024

Ozempic is a GLP-1 agonist and is actually marketed as a diabetes drug, but many physicians are prescribing it for weight loss (off label-use). Ozempic’s label warns, “In studies with rodents, Ozempic® and medicines that work like Ozempic® caused thyroid tumors, including thyroid cancer. Epub 2011 Dec 14. Eur J Endocrinol.

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Diabetes Immunity Immunization Compounding 83