Remove Adverse Reactions Remove Documentation Remove Labelling
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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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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. By accurately documenting the movement of drugs, manufacturers can identify any quality issues that may arise during production, storage, or transportation.

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How advanced technology can streamline the COVID-19 vaccine rollout

pharmaphorum

Adverse reactions to the vaccine. The data must be quickly documented and reported to public health agencies to ensure effective record keeping, equal access to the vaccine and patient safety. In a rollout of this magnitude, point of care facilities need to collect comprehensive vaccination data on: Individual patient records.

Vaccines 119
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FDA Accepts Pfizer’s sNDA for BRAFTOVI + MEKTOVI

LifeProNow

These sNDAs are supported by results from the PHAROS trial ( NCT03915951 ), an open-label, multicenter, non-randomized, Phase 2 study (n=98) to determine the safety, tolerability, and efficacy of BRAFTOVI given in combination with MEKTOVI in patients with BRAF V600E-mutant metastatic NSCLC. of patients.

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The MAHA Assessment’s Implications: Drugs (Part One)

FDA Law Blog: Biosimilars

There are also drugs the Assessment identifies as being used off-label without high-quality evidence or for uses that are approved but without rigorous true placebo-controlled trials (namely vaccines) and/or with known safety concerns. That leaves us to speculate what the implications of this Assessment will be.

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FDA Issues Complete Response Letter to Manufacturer of OLC, Treatment for CKD-Related Hyperphosphatemia

Pharmacy Times

Common adverse reactions included gastrointestinal issues, with a low discontinuation rate due to adverse drug reactions. The manufacturer reported that, as part of the NDA review, they have not highlighted any technical concerns related to the submitted documentation or testing of OLC.

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BMS Submits Application for Abecma® for Relapsed or Refractory Multiple Myeloma

LifeProNow

The primary endpoint evaluated in this study is progression-free survival, defined as time from randomization to the first documentation of progressive disease or death due to any cause, whichever occurs first. and Europe.” Key secondary endpoints include overall response rate and overall survival.