The FDA Law Blog

SEPTEMBER 19, 2023

Karst — Listing patent information in the Orange Book is a matter of judgment, but that judgment call is about to get a bit more scrutiny. Last week, the FTC held a Listening Session about the listing of patents in the Orange Book, which concluded with a unanimous vote to issue a Policy Statement.

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FDA Communication Dosage 105

The Thyroid Pharmacist

SEPTEMBER 20, 2024

Plecanatide : This is one of the newest medications for IBS-C that has been approved by the FDA. Tenapanor : Tenapanor was approved by the FDA in September of 2019 for IBS-C. [49] Vitamin D deficiency is common, and many people supplement with it, but there can be too much of a good thing! I wish you well on your healing journey!

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Health and Personal Care Stores Chemotherapy Immunization Compounding 62

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. Dietary Changes.

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Dosage Labelling Communication FDA 122

The Thyroid Pharmacist

OCTOBER 27, 2023

These signals create communication and function within nerves and muscles, as the electrolytes move in or out of cells. Humic extract, the main ingredient, contains fulvate, which helps the cells in our gut better communicate with each other and bacteria. It also helps clear glyphosate out of the body.

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Health and Personal Care Stores Immunization Compounding Packaging 88

The Thyroid Pharmacist

FEBRUARY 10, 2023

You can learn more about this in my book, Adrenal Transformation Protocol. After doing the targeted interventions outlined in my adrenal program and book, many of my clients have reported feeling more like “themselves” and even see major improvements in symptoms that had been with them for decades, in just two to four weeks.

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Documentation Dosage FDA Labelling 98

The Thyroid Pharmacist

JANUARY 20, 2023

It has been 10 years since I wrote my first book on Hashimoto’s, yet at the time of writing, there was no “official research” to connect stress to Hashimoto’s and hypothyroidism. I love using adrenal adaptogens, especially during my own peak periods of stress (did someone say, “holidays” or “book deadline”?)

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HIV Treatment and Prevention Agents Immunization Compounding Documentation 98

Pharmaceutical Technology

JANUARY 6, 2023

Last year, Novartis began with a win in January, as the US Court of Appeals affirmed the validity of Gilenya’s patent, allowing the company to sue a competitor generics company for filing for FDA approval for its Gilenya generic. Gilenya is an oral medication for multiple sclerosis. Fighting Entresto generics.

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Documentation FDA Hospitals Dosage 97