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Last week, FDA released a draft guidance, “ Labeling for Biosimilar and Interchangeable Biosimilar Products ” (“2023 Draft Guidance”) that—when finalized—will revise and replace its July 2018 final guidance, “ Labeling for Biosimilar Products.”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

RX Note

FDA Pregnancy and Lactation Labelling Final Rule, 2015 In the past, FDA Pregnancy Categories was used in US. To address this, on 13 December 2014, the FDA published the Pregnancy and Lactation Labelling Rule” (PLLR). Labelling for prescription drugs approved on or after June 30, 2001, will be phased in gradually.

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Ministry of Health Medicines Formulary (MOHMF)

RX Note

Introduction The Ministry of Health Medicines Formulary (MOHMF), “Formulari Ubat Kementerian Kesihatan Malaysia (FUKKM)", or sometimes known as Blue Book, is a list of medications that we can use in Ministry of Health (MOH) facilities. It is typically updated 2-3 times a year to add, modify or delist the medications in it.

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Difference between Prescription vs Non-prescription drugs

FADIC

These include guidelines for the following: Acceptable ingredients Dosages Formulations Labeling requirements As long as a drug follows an OTC monograph, it can be marketed and sold without any further review or approval from the FDA. Labeling Labeling requirements also differ for prescription and OTC drugs.

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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. In the pharmaceutical world of bookings, dispensing, clinical decisions, and customer service, AI integration is on the up.

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Low Dose Naltrexone and Hashimoto’s

The Thyroid Pharmacist

Dr. Bernard Bihari is credited with making these discoveries about using naltrexone off-label, at lower doses. IW: What are some of the more common adverse reactions that people have to LDN? I talk about this more in my books, Hashimoto’s Thyroiditis: The Root Cause , Hashimoto’s Protocol , and Adrenal Transformation Protocol.