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Drug Recall

RX Note

Classification Drug recalls can be classified to: 3 degrees based on the severity of quality defects and adverse reactions of the products Degree I: Products with major health risks that might cause serious injuries or death. Should be under an embargo within 24 hours. Degree II: Products with minor health risks or are substandard.

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Anaemia in Chronic Kidney Disease

RX Note

External Links KDIGO CPG for Anemia in Chronic Kidney Disease, 2012 KDOQI Clinical Practice Guidelines and Clinical Practice Recommendations for Anemia in Chronic Kidney Disease, 2006 KDOQI US Commentary on the 2012 KDIGO Clinical Practice Guideline for Anemia in CKD, 2013 Recombinant human erythropoietins: very rare risk of severe cutaneous adverse (..)

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Teething

RX Note

Viscous lidocaine has been associated with serious adverse reactions ( including death ) in young children being treated for mouth pain, including teething. Says, 2016 FDA takes action against the use of OTC benzocaine teething products due to serious safety risk, lack of benefit, 2018

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FDA grants full approval for Roche/AbbVie’s Venclexta in AML combination therapies

pharmaphorum

The combination therapies had previously been marketed following accelerated approval in November 2018 on the basis of early stage results. Combination therapies involving Roche and AbbVie’s cancer drug Venclexta have been formally approved by the FDA in acute myeloid leukaemia, following supportive data from late-stage studies.

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New Bill could enhance UK clinical trial regulation

European Pharmaceutical Review

He highlighted research by the Association of the British Pharmaceutical Industry (ABPI) from 2022, which found that between 2018 and 2020, “the median time between application for regulatory approval and delivery of a first dose to a participant in a trial increased by almost a month.”

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Last week, FDA released a draft guidance, “ Labeling for Biosimilar and Interchangeable Biosimilar Products ” (“2023 Draft Guidance”) that—when finalized—will revise and replace its July 2018 final guidance, “ Labeling for Biosimilar Products.”

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Timing of Medication

RX Note

Selective serotonin reuptake inhibitors, serotonin and norepinephrine reuptake inhibitors, tricyclic antidepressants, and monoamine oxidase inhibitors can cause either activating or sedating adverse reactions. Some adverse reactions can be used as an advantage. 2018 What time of day should I take my medicine?,