The FDA Law Blog

MAY 11, 2023

GSK skinny label case , the U.S. Specifically, the Government explained, “[t]he section viii pathway cannot function properly if FDA and generic manufacturers cannot rely on an NDA holder’s representations to the agency regarding which portions of the brand-name drug’s labeling teach patented methods of use.”

Labelling 72

Labelling FDA Documentation Communication 72

Hospital Pharmacy Europe

JANUARY 16, 2025

Here, lead author and focus group chair Hala Fadda discusses the reasons for widespread off-label prescribing, the FIP studys rationale and main findings, compounding challenges and considerations for improving clinical practice.

Compounding 119

Compounding Labelling Dosage Hospitals 119

The FDA Law Blog

AUGUST 21, 2023

Livornese — I saw the sign…and the answer is no—FDA-approved labeling apparently is not enough under state failure-to-warn laws, according to certain courts.

Labelling 40

Labelling FDA Vaccines Communication 40

The Checkup by Singlecare

OCTOBER 30, 2023

In addition, sertraline is prescribed for several other off-label indications, including binge eating disorder and body dysmorphic disorder, even sexual dysfunction conditions like premature ejaculation. Therefore, any onset of symptoms should be managed by immediate communication with a healthcare professional.

Mayo Clinic 52

Mayo Clinic Communication Labelling FDA 52

The Checkup by Singlecare

FEBRUARY 6, 2024

The product labeling for methadone strongly advises exploring alternative options instead of using a combination of these two medications. Breastfeeding women prescribed fluconazole should openly communicate the risks and benefits, or possible alternatives, with their medical provider.

Communication 52

Communication Dosage Labelling Hospitals 52

The Thyroid Pharmacist

OCTOBER 6, 2023

Check food labels carefully, and be extra careful if you are eating out, as it’s difficult to know all of the ingredients used in restaurants. 2007; 85(5): 1185-96. It may be best to avoid eating out during this elimination period, to avoid any cross-contamination that might skew your results. References [1] Maintz L, Novak N.

Health and Personal Care Stores 98

Health and Personal Care Stores Immunization Dosage Compounding 98

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. Precautions Do not take more than the recommended dose on the label. Humic extract, the main ingredient, contains fulvate, which helps the cells in our gut better communicate with each other and bacteria.

Health and Personal Care Stores 99

Health and Personal Care Stores Immunization Compounding Packaging 99