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. Brand drugs, generic drugs, and medical devices alike have all been the target of state failure-to-warn litigation; in a recent case, OTC acetaminophen is the target. But we digress.

Labelling 40

Labelling FDA Vaccines Communication 40

The FDA Law Blog

MAY 11, 2023

government in the now-infamous (at least in FDA circles) Teva v. If an FDA-approved carve-out could support an intent to induce infringement claim, the use of the “section viii pathway would be substantially deterred.” Plainly, the Government brief states “The decision below is incorrect. GSK skinny label case , the U.S.

Labelling 72

Labelling FDA Documentation Communication 72

ISPE

MARCH 8, 2023

Identification and Analysis of Contamination Trends Three major recall databases—those of the US FDA, the United Kingdom’s Medicine and Healthcare Products Regulatory Agency (UK MHRA), and Australia’s Therapeutic Goods Administration (TGA)—were searched to assess contamination trends in the past five years.

Compounding 52

Compounding Compounding Pharmacies Packaging FDA 52

The Checkup by Singlecare

FEBRUARY 6, 2024

Breastfeeding women prescribed fluconazole should openly communicate the risks and benefits, or possible alternatives, with their medical provider. Directly communicate with a healthcare professional when needing fluconazole, including a single dose for vaginal yeast infections.

Communication 52

Communication Dosage Labelling Hospitals 52

The Checkup by Singlecare

OCTOBER 30, 2023

Sertraline carries multiple Food and Drug Administration (FDA) approvals, including major depressive disorder (MDD), obsessive-compulsive disorder (OCD), panic disorder, posttraumatic stress disorder (PTSD), premenstrual dysphoric disorder (PMDD), and social anxiety disorder.

Mayo Clinic 52

Mayo Clinic Communication Labelling FDA 52

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. 2007-2404. [9] It also helps clear glyphosate out of the body. 9] White D.

Health and Personal Care Stores 71

Health and Personal Care Stores Immunization Compounding Packaging 71

ISPE

OCTOBER 26, 2022

For example, an assessment for a facility primarily focused on US and EU markets would only consider GMPs and regulations from EudraLex and the FDA. FDA CFR Title 21 Parts 211, 600, and 1271; 8. , FDA Guidance for Industry: Sterile Drug Products Produced by Aseptic Processing–Current Good Manufacturing Practice, 11.

Vaccines 97

Vaccines Compounding Documentation FDA 97