Eye on FDA

AUGUST 2, 2022

The 4 letters issued this calendar year: Involved 3 Untitled Letters and 1 Warning Letter – a profile not out of proportion given that about 33 percent of letters issued since 2004 have been Warning Letters. The characterization of investigative data resulted in a violation related to promotion of an unapproved compound.

Communication 88

Communication Pharmaceutical Companies Pharmaceutical Companies Documentation 88

European Pharmaceutical Review

JULY 4, 2024

However, as with drugs, dietary supplements require evidence that they are safe and that claims on product labels are truthful and not misleading. 10 Directive 2004/24/EC introduced a registration scheme for traditional herbal medicines and requires herbal remedies sold over the counter in the UK to be registered. 2012/1916).

Drug Development 103

Drug Development Biosimilars Documentation Labelling 103

European Pharmaceutical Review

JULY 5, 2022

Introducing an irinotecan tablet formulation, in combination with other effective oral compounds, provides the opportunity for patients to receive an all-oral, metronomic chemotherapy with better efficacy in a more convenient and cost-effective regimen. accessdata.fda.gov/drugsatfda_docs/label/2014/020571s048lbl.pdf [Accessed 25.01.22].

Chemotherapy 104

Chemotherapy Dosage Labelling Compounding 104

The Thyroid Pharmacist

AUGUST 19, 2022

Source: Bertalot et al, 2004). Source: Bertalot et al, 2004). Thymoquinone (TQ), one of the active compounds found in black seed oil, acts as a biofilm disruptor, meaning that it can break free from the protective coating that H. The five patients with Hashimoto’s and untreated H. pylori continued to have high TPO and TG levels.

Health and Personal Care Stores 98

Health and Personal Care Stores Immunity Immunization Dosage 98

The Thyroid Pharmacist

JULY 8, 2022

Interestingly, a 2004 study found an association between the presence of an anxiety or mood disorder, and the presence of thyroid peroxidase (TPO) antibodies. (4). Published 2004 Aug 18. 2004 Jun;18(2):303-16. Institute of Medicine (US) Panel on Dietary Antioxidants and Related Compounds. BMC Psychiatry. J Thyroid Res.

Dosage 59

Dosage Immunity Immunization Diabetes 59

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. Published 2004 Aug 18.

Dosage 122

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] 2004-0395 [36] Mutlu HH, Mutlu HH. J Clin Endocrinol Metab. 2008 Jul;93(7):2559-65. doi: 10.1210/jc.2007-2404. 2007-2404.

Immunity 105

Immunity Immunization Diabetes Dosage 105