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Last week, FDA released a draft guidance, “ Labeling for Biosimilar and Interchangeable Biosimilar Products ” (“2023 Draft Guidance”) that—when finalized—will revise and replace its July 2018 final guidance, “ Labeling for Biosimilar Products.” The fictitious example provided in the 2023 Draft Guidance is “replicamab-cznm.”

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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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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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Micromedex

RX Note

In my experience, there are increasingly more off-label uses and dosages included in this resource. External Links NeoFax® Neonatology Drug and Enteral Nutrition Reference Book Discontinued in Print Format as of June 2012; Now Available Via the Web by Subscription, 2012 IBM to acquire Truven Health Analytics for $2.6

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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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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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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. <–