FDA Law Blog: Biosimilars

JANUARY 18, 2024

within the CSA’s definition of “marihuana” or “marijuana” based on FDA’s eight factor analysis. whether growing or not; its seeds; resin extracted from any part; and every compound, manufacture, salt, derivative, mixture, or preparation of the plant, its seeds or resin. 21 U.S.C. § 802(16)(A). 21 U.S.C. § 802(16)(B).

Controlled Substances 69

Controlled Substances Chemotherapy Compounding Dosage 69

Pharma in Brief

JANUARY 25, 2023

Combination use : The FC found that a generic manufacturer’s single-compound product would induce infringement of claims to a combination therapy (see here ). Such cases typically concern “skinny labels” in which the generic seeks to avoid reference to indications related to the patented use.

Biosimilars 52

Biosimilars Dosage Labelling Compounding 52

The Thyroid Pharmacist

JULY 8, 2022

The good news is that supplementing with selenium at a therapeutic dosage, has been found to reduce thyroid antibodies, reduce thyroid symptoms, and improve overall well-being. (1-3). Half of the participants were given selenium supplementation at a dosage of 200 mcg per day, along with levothyroxine, for a 90-day period.

Dosage 59

Dosage Immunity Immunization Diabetes 59

The Thyroid Pharmacist

SEPTEMBER 23, 2022

Other plants also contain this organic compound, but aloe vera contains an especially large amount, with over 12 different anthraquinones. The active compounds found in aloe vera have been found to have immune-modulating benefits. You can read more about treating underlying infections to reverse Hashimoto’s here. Immune Health.

Immunity 98

Immunity Immunization Compounding Diabetes 98

The Thyroid Pharmacist

FEBRUARY 17, 2023

As individual needs may vary, I highly recommend working with a healthcare practitioner to determine optimal dosages for your condition. NAC’s sulfurous compounds can often cause a “rotten-egg” smell — but that is normal! I would generally take this supplement with food to avoid stomach upset.

Diabetes 98

Diabetes Immunity Immunization Dosage 98

RX Note

JUNE 3, 2023

Who are allowed to dispense or compound any poison for use in medical treatment? What is the definition of Zero and first order reaction Bioavailability Elimination rate constant Half-life Steady-state Given a drug has volume distribution of 0.2 What are the minimum requirements for Group B poisons prescription?

Health and Personal Care Stores 40

Health and Personal Care Stores Chemotherapy Compounding Dosage 40

PharmaTech

JUNE 12, 2025

While FDA warning letters generally do not authorize the execution of any definitive actions by the agency, they do specify actions that may be taken if FDA’s suggestions and requests are not adhered to, usually to be communicated by a company within a window of 15 business days of receipt of FDA’s letter.

Dosage 59

Dosage Drug Development Labelling Compounding 59

The Thyroid Pharmacist

JULY 20, 2023

While dietary adjustments and supplementation can definitely help, time and again, I see it’s not so easy for some people (and yes, it’s true – I am “some people”, too)! Anemia by definition is having a low level of red blood cells. The body needs red blood cells in order to get oxygen from the lungs, to the rest of the body.

Health and Personal Care Stores 98

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

The Thyroid Pharmacist

JULY 7, 2023

A dosage of 200 mcg per day has been found to reduce thyroid antibodies in clinical trials. [41] 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]

Immunity 105

Immunity Immunization Diabetes Dosage 105

The Thyroid Pharmacist

APRIL 11, 2025

While it’s uncommon for people without celiac disease to completely stop taking thyroid medication solely by going gluten free, some do find they can reduce their dosage through a gluten-free diet. Additionally, the definition of euthyroidism was a TSH of 3.18 +/- 1.22 units, which in my opinion is a bit too high.

Immunity 71

Immunity Immunization Dosage Diabetes 71