Putting Patients First Blog

SEPTEMBER 3, 2024

Manufacturer-Focused Input Question 30: Off-Label Use. CMS has appropriately highlighted the significance of off- label use information, providing a specific avenue for manufacturers to submit data on off-label uses supported by evidence-based guidelines listed in CMS-recognized Part D compendia. doi: 10.1016/j.jaad.2020.06.998

Drug Pricing 52

Drug Pricing Insurance Coverage and Processing Labelling Communication 52

Putting Patients First Blog

JULY 2, 2024

The NHC requests more clarity on how CMS will exclude QALY-based metrics and highlight when they have been removed from consideration in MFP justification documentation. Off-label usage often emerges from real- world clinical practice and patient experiences, which might not be reflected in the guidelines. doi: 10.1016/j.jaad.2020.06.998

Drug Pricing 52

Drug Pricing Insurance Coverage and Processing Labelling HIPAA 52

Pharma in Brief

JANUARY 17, 2021

Pharmascience obtained approval for a 20 mg strength of its product, Glatect ® , in August 2017. The Court found that the prior art documents cited by Pharmascience ( Pinchasi 2007 and Karussis 2006 ) neither disclosed nor enabled the asserted claims of the 437 Patent. Teva argued that Glatect ® 40 mg will infringe Canadian Patents No.

Dosage 52

Dosage Documentation Labelling 52

PharmaTech

JUNE 23, 2025

Thakar Varanya Chaiyaperm View All News Article Bulk drug calculations for different types of active moieties and drugs require different calculations and labeling. It builds on drug calculations topics previously described (1), including guidance documents (2–5). Labeling for the primary and secondary labels are determined.

Compounding 52

Compounding Dosage Labelling Drug Development 52

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).

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Health and Personal Care Stores Labelling Immunity Immunization 88

Pharma in Brief

JANUARY 9, 2022

Health Canada also consulted on proposed guidelines for the use of electronic media in prescription drug labelling (see here ). The major amendments to the PM(NOC) Regulations , made in 2017, continue to be interpreted by the FC and the FCA. Proposed amendments to the PM(NOC) Regulations were also introduced in 2021.

Documentation 52

Documentation Labelling Vaccines Packaging 52

The Thyroid Pharmacist

JULY 14, 2023

I’m excited to report that since the initial publication of this article in 2017, various individuals and companies have created more accessible, direct-to-consumer devices to provide red light therapy; most of them use LEDs instead of lasers. While lasers have the most research behind them, they’re also the least accessible. doi:10.1089/thy.2010.0102;

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Dosage Immunity Immunization Documentation 98

The Thyroid Pharmacist

JULY 29, 2022

Perhaps more concerning, of the 133 different VOCs found across all tested products, only one, ethanol, was actually listed on any label! (13, For sunscreens and other over-the-counter drugs, fragrances must be identified on the label. But formaldehyde has been labeled as a known human carcinogen by the U.S.

Health and Personal Care Stores 52

Health and Personal Care Stores Compounding Immunity Immunization 52

FDA Law Blog: Biosimilars

DECEMBER 1, 2024

FDA reports that it told the company that “failure to allow photography would be documented as a refusal,” and the company “acknowledged the refusal.” Management, according to the Warning Letter, “stated that the investigators were not allowed to take photographs of the equipment as part of the inspection.”

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Documentation Labelling 113

The Thyroid Pharmacist

FEBRUARY 10, 2023

A few years ago, I had a few clients with documented elevations in prolactin, and I have seen that lowering prolactin levels can help with reducing thyroid antibodies. Studies have, however, documented that bromocriptine, a medication used to lower prolactin levels, can reduce flares in lupus, another autoimmune condition.

Dosage 98

Dosage Documentation Diabetes Labelling 98

RX Note

FEBRUARY 9, 2025

Labelling format Generic name of medication Name of manufacturer or distributor Dosage form, including special designations (e.g. Repackage only one medication at a time Prepare only the number of labels that will be needed for the repackaging run. Do not prepare extra labels.

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Packaging Labelling Dosage Documentation 40

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 In one small study published in 2017 in the Journal of Complementary Medicine , after eight weeks of treatment, ashwagandha was found to improve serum TSH, T3 and T4 levels, normalizing serum levels. [14]

HIV Treatment and Prevention Agents 98

HIV Treatment and Prevention Agents Diabetes Immunity Immunization 98

The Thyroid Pharmacist

MAY 12, 2025

25] There have also been documented cases of improved egg quality and spontaneous pregnancies following PRP, both naturally and through IVF. 2017 Guidelines of the American Thyroid Association for the Diagnosis and Management of Thyroid Disease During Pregnancy and the Postpartum [published correction appears in Thyroid.

Immunity 57

Immunity Immunization Dosage Documentation 57

The Thyroid Pharmacist

NOVEMBER 8, 2024

In 2017, I began using the GI-MAP stool test for most clients and recommending it for participants in my Hashimoto’s Self-Management Program. Between 2017 and 2019, my team and I were able to collect and analyze the data from 298 GI-MAP tests. Those added in December of 2017 were: Epstein-Barr Virus Cytomegalovirus Rhodotorula spp.

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Immunity Immunization Diabetes Adverse Reactions 80