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

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

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

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

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

SEPTEMBER 20, 2024

Plecanatide : This is one of the newest medications for IBS-C that has been approved by the FDA. Tenapanor : Tenapanor was approved by the FDA in September of 2019 for IBS-C. Tegaserod : This medication was approved for IBS-C in 2002, but removed from the market in 2007 due to an increased risk of cardiovascular events.

Health and Personal Care Stores 75

Health and Personal Care Stores Chemotherapy Immunization Compounding 75

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