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

The FDA Law Blog

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.

FDA
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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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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.

FDA
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Pharmaceutical Compounding Calculations, Part Two–Bulk Drugs

PharmTech

Thakar Varanya Chaiyaperm View All News Article Bulk drug calculations for different types of active moieties and drugs require different calculations and labeling. Part two discussion describes a simple medication order and demonstrates calculations and labeling for each bulk drug type. Pluta Nishant B.

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Unicorns Don’t Exist: Rethinking the Generalist Model in Oncology Pharmacy

Pharmacy Times

There are too many drug approvals, label updates, and new data published for even the most skilled and experienced oncology pharmacist to keep up with, let alone those still building their baseline knowledge. Touchstone Books; 2013. Oncology pharmacy practice changes at a rapid pace. Time Enough for Love. Putnam’s Sons; 1973.

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Fentanyl facts and statistics

The Checkup by Singlecare

It can be prescribed off-label for certain types of pain, especially severe acute pain or pain caused by cancer. Fentanyl may also be prescribed off-label, meaning for a purpose other than what the Food and Drug Administration (FDA) approved it for. As of Sept. SAMHSA, 2024) In 2022, only 1 in 4 U.S. deaths per 100,000 people in 2023.

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Side effects of Trintellix when starting

The Checkup by Singlecare

In 2013, the Food & Drug Administration approved Trintellix for use in treating symptoms of MDD, a severe and often chronic form of depression. But it is sometimes prescribed off-label for some anxiety disorders. What is Trintellix used for?