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The Great RIF(T): One FDA Division’s Destruction and What it Could Mean for Generic Drugs

FDA Law Blog: Biosimilars

Leading FDAs policy implementation of the MODERN Labeling Act , the statutory authority allowing FDA to make certain generic drug labeling updates. Since the inception of the program, DPD reportedly met every GDUFA goal date for timely issuance of a CPA.

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Drug Storage

RX Note

Introduction Once, I received a query from a ward nurse: If a product label mentioned that "Do not store over 25°C", is it fine for us to keep the medication in fridge? What does a cool place on the product label mean? Read the label to know the recommended storage temperature range.

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FDA Abandons Its Defense of the LDT Rule, But is It Signaling an Increase in RUO Scrutiny?

FDA Law Blog: Biosimilars

RUO-labeled reagents and materials are often used in LDTs in clinical laboratories. Indeed, FDA states, the existence of a certification program alone would not relieve manufacturers from their responsibilities to ensure that their labeling and distribution practices for RUO/IUO products are consistent with the products RUO/IUO label.

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GE HealthCare’s PET imaging agent gains Alzheimer’s label expansion

Pharmaceutical Technology

The updated label for GE HealthCare’s positron emission tomography (PET) imaging agent Vizamyl (flutemetamol F 18 injection) now includes quantification of amyloid in the brain, meaning patients taking an anti-amyloid therapy can be monitored for the drug’s effectiveness. “Now Don’t let policy changes catch you off guard.

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Brand Name Search

RX Note

Off label use information can be found here too. External Links TGA - Updating medicine ingredient names - list of affected ingredients, 2020 Multiple Brand Names for the Same Generic Drug Can Cause Confusion, 2013 A different drug, a different country, but the same brand name?,

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GSK’s world-first gonorrhoea vaccine launched in England

Pharmaceutical Technology

The vaccine was approved in Europe in 2013, with the UK becoming the first country to offer the vaccine as part of its routine childhood immunisation schedule in 2015. As protection against gonorrhoea is not currently a licensed indication for the 4CMenB vaccine in England, the programme utilises off-label use of the vaccine.

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Lumateperone Submits Application for Schizophrenia Indication to FDA for Supplemental New Drug

Pharmacy Times

If approved, lumatperone’s expanded label could offer health care teams a valuable tool to improve stability, well-being, and real-world outcomes for patients with schizophrenia. 1-3 REFERENCES 1. Johnson & Johnson. Factors associated with relapse in schizophrenia despite adherence to long-acting injectable antipsychotic therapy.