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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Last week, FDA released a draft guidance, “ Labeling for Biosimilar and Interchangeable Biosimilar Products ” (“2023 Draft Guidance”) that—when finalized—will revise and replace its July 2018 final guidance, “ Labeling for Biosimilar Products.” The fictitious example provided in the 2023 Draft Guidance is “replicamab-cznm.”

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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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Episode 902: The analgesic ceiling dose of ibuprofen applies to ED patients too

Pharmacy Joe

Back in episode 473 , I talked about the evidence behind the discrepancy between the labeled dose and the analgesic ceiling dose of IV ketorolac. If you like this post, check out my book – A Pharmacist’s Guide to Inpatient Medical Emergencies: How to respond to code blue, rapid response calls, and other medical emergencies. <–

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Drug Formulary App

RX Note

It is a quick reference for indication, dosage, availability and prescribing category. Blue Book + CPG Malaysia under Ice Cream App Database last updated to MOHMF 2022-1. Similarly, the off-label uses can be clearly highlighted too. Although the website is a possible solution, there is no official mobile application available.

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The Most Common OTC Resource

FADIC

People can follow the “Drug Facts Label” directions on OTC products for proper use. They can encourage them to read the labels of OTC products thoroughly and always ask questions if they are uncertain about their choice and proper use. Patient advocacy: Pharmacists advocate for their patients’ health and well-being.

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The Missing Link to Thyroid Fatigue

The Thyroid Pharmacist

Please note: Some people may need to increase their dosage of thiamine from 600 mg per day. It looked at the effect of thiamine on patients with Crohn’s disease and ulcerative colitis, and found that effective dosages ranged from 600 mg to 1,500 per day, depending on individual body size. [7]

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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.