Remove Adverse Reactions Remove Information Remove Labelling
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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Last week, FDA released a draft guidance, “ Labeling for Biosimilar and Interchangeable Biosimilar Products ” (“2023 Draft Guidance”) that—when finalized—will revise and replace its July 2018 final guidance, “ Labeling for Biosimilar Products.”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. Here are some resources that can provide you with the best information on OTC drugs. Link National Institutes of Health (NIH) The NIH is a part of the U.S.

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Pharmacovigilance deep dive: risk minimisation measures

European Pharmaceutical Review

This can be achieved by reducing the burden of adverse reactions or by optimising benefits through patient selection (eg, contraindications, recommendations of use, warnings, concomitant medicine[s], or certain test parameters) and treatment management (eg, specific dosing regimen, relevant testing, patient follow-up).

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Clinical Pharmacology by ClinicalKey

RX Note

Introduction Clinical Pharmacology powered by ClinicalKey provides current, dependable drug information, including off-label indications, to guide treatment recommendations. Drug Class Overviews Provides information on therapeutic use, comparative efficacy, adverse reactions and drug interactions.

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

Express Pharma

This widespread issue has led to treatment failures, adverse reactions, and even loss of life among patients. These systems enable real-time monitoring, accurate data capture, and seamless integration of information across various stakeholders, from manufacturers to healthcare providers.

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How advanced technology can streamline the COVID-19 vaccine rollout

pharmaphorum

That information is then immediately uploaded to the cloud for employees to reference. Adverse reactions to the vaccine. After collecting the information, they print a plastic barcode label that can send the recipient’s vaccination records to the cloud with a simple scan. Daily vaccination numbers.

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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. However, this category system has proven to be confusing and overly simplistic, lacking sufficient information on potential risks. Labelling for prescription drugs approved on or after June 30, 2001, will be phased in gradually.