Remove Adverse Reactions Remove Documentation Remove Events
article thumbnail

IPC alert advises patients to monito possibility of mefenamic acid’s adverse effects: Meftal makers

Express Pharma

DRESS syndrome, mentioned in the IPC alert, is a very rare event that is previously documented in medical literature, both in India and globally. The post IPC alert advises patients to monito possibility of mefenamic acid’s adverse effects: Meftal makers appeared first on Express Pharma.

article thumbnail

Adverse Drug Reactions

RX Note

Adverse Drug Reactions The World Health Organization (WHO) defines an adverse drug reaction (ADR) as 'a drug-related event that is noxious and unintended and occurs at doses normally used in man for the prophylaxis, diagnosis or therapy of disease, or for modification of physiological function'. Is it safe?

Insiders

Sign Up for our Newsletter

This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.

article thumbnail

How to Run DMC? It’s Tricky – FDA’s New Draft Guidance Provides Updated Recommendations on How to Best Use Data Monitoring Committees in Clinical Trials

FDA Law Blog: Biosimilars

Other Oversight Groups Both documents described the role of other oversight groups, in addition to DMCs, that may be involved in a clinical trial in similar, sometimes overlapping, roles such as IRBs, trial steering committees, and site monitors. Increased Connections Between a DMC and FDA?

article thumbnail

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.

article thumbnail

How using AI in clinical trials accelerates drug development

Pharmaceutical Technology

During these phases, data is obtained from participants and monitored for adverse reactions or changes to health indicators, such as blood pressure or heart rate. For example, important information may be locked in knowledge silos or gained through experience, making it difficult to find or document.

article thumbnail

Medication Therapy Management in geriatric

FADIC

Aim The role of MTM provider to geriatric patient to reduce the rate of adverse drug event caused by medication errors, drug interactions. ■ All follow-up evaluations and interactions with the patient and his or her other healthcare professional should be included in MTM documentation.

article thumbnail

FDA Accepts Pfizer’s sNDA for BRAFTOVI + MEKTOVI

LifeProNow

Withhold, reduce dose, or permanently discontinue based on severity of adverse reaction. The most frequent hemorrhagic events were gastrointestinal, including rectal hemorrhage (4.2%), hematochezia (3.1%), and hemorrhoidal hemorrhage (1%). Withhold, reduce dose, or permanently discontinue based on severity of adverse reaction.