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FDA Releases Draft Labeling Guidance for Biosimilar Products

Big Molecule Watch

Last week, FDA released a draft guidance, “ Labeling for Biosimilar and Interchangeable Biosimilar Products ” (“2023 Draft Guidance”) that—when finalized—will revise and replace its July 2018 final guidance, “ Labeling for Biosimilar Products.”

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Over-the-Counter Choices Pharmacist Role and Resources

FADIC

OTC drugs come in various forms, including tablets, capsules, creams, and liquids, and are generally labeled with clear instructions on proper usage and dosage. The FDA’s website provides a wealth of information on OTC drugs, including product labels, warnings, and recalls.

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How authentication of drugs has become a fundamental pillar of patient safety

Express Pharma

Counterfeit drugs, intentionally mislabeled or misrepresented, often contain substandard or harmful ingredients, incorrect dosages, or no active ingredients at all. This widespread issue has led to treatment failures, adverse reactions, and even loss of life among patients.

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US FDA approves AbbVie-Janssen’s Imbruvica for cGVHD in children

Pharmaceutical Technology

The dosage indicated for patients aged one year to under 12 years is once a day, oral 240mg/m2 dose of Imbruvica. Imbruvica's safety was reported to be in line with its established profile and the observed adverse reactions (ARs) were similar to those seen in adults with moderate to severe cGVHD.

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Difference between Prescription vs Non-prescription drugs

FADIC

Drug manufacturers also have to submit details about how the drug works in the human body, guidelines for dosage, and information on safety and side effects. Labeling Labeling requirements also differ for prescription and OTC drugs. This way, a person can self-diagnose and treat their symptoms by reading the label.

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OPDP Says TV Ad is Out of Bounds with Fourth Untitled Letter of 2024

FDA Law Blog: Biosimilars

The approved labeling for UBRELVY includes a warning and precaution regarding hypersensitivity reactions, with the most common adverse reactions being nausea and somnolence.

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How Long Until AI Starts to Replace Pharmacists

pharmacy mentor

AI algorithms can analyse patient data to predict potential drug interactions, customise treatment plans, and even identify early signs of adverse reactions. Dosage Recommendations : AI tools such as Dosis can analyse patient-specific data (e.g.