Remove 2020 Remove Adverse Reactions Remove Labelling
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STAT+: Experts critique flawed system for monitoring drugs’ side effects in wake of asthma drug report

STAT

and globally, for monitoring adverse reactions after a drug is on the market — one that will require extensive changes to address. Experts say that the Singulair incident highlights a flawed system, both in 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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OPDP Says TV Ad is Out of Bounds with Fourth Untitled Letter of 2024

FDA Law Blog: Biosimilars

The approved labeling for UBRELVY includes a warning and precaution regarding hypersensitivity reactions, with the most common adverse reactions being nausea and somnolence. on March 10, 2020.

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Nextstellis®: A new drug update 

Birth Control Pharmacist

Adverse Reactions. The most common adverse reactions (>2%) were bleeding irregularities, dysmenorrhea, headaches, mood disturbance, increase weight, acne, decrease libido and breast symptoms. Available at: www.accessdata.fda.gov/drugsatfda_docs/label/2021/214154s000lbl.pdf. Published April 7, 2020.

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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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9 Sneaky Thyroid Toxins Hiding in Your Home

The Thyroid Pharmacist

to fluoride in my tap water, to hidden mold in my home, to my shampoo and deodorant (have you ever read those labels?!), 16] Even more concerning, of the 133 different VOCs found across all tested products, only one, ethanol, was actually listed on any label! From indoor pollutants like formaldehyde (yes, really!),

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Five Things For Pharmacists To Know About The Treatment Of Mycobacterium Tuberculosis

ID Stewardship

An accessible guide encompassing key subjects in epidemiology, diagnosis, laboratory considerations, treatment, medication, co-morbidities, special circumstances, monitoring, and managing adverse reactions. Geneva, World Health Organization, 2020. 2011;365(23):2155–2166. World Health Organization.