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Guatemala

Colombia Signs Agreement With PAHO To Strengthen Regulatory Capacity

Colombia Signs Agreement With PAHO To Strengthen Regulatory Capacity

The deal comes at a time when Latin American countries are increasingly looking to improve the regulatory environment for pharmaceuticals and move towards greater convergence.

US FDA Gets Lesson In 'Unintended Consequences' From Relaxing Sanitizer Production Standards

US FDA Gets Lesson In 'Unintended Consequences' From Relaxing Sanitizer Production Standards

More than 6.2m containers of sanitizers have been recalled since mid-October due to methanol contamination. Total includes 67,440 made by Genesis Partnership Co., the first manufacturer in Guatemala that the FDA identified as making contaminated hand sanitizers distributed in the US.

Stunted Newborn Risk Cut 31% With Lipid Supplement For Women

Stunted Newborn Risk Cut 31% With Lipid Supplement For Women

RCT with 7,300 women in four countries shows women who take a lipid-based supplement before pregnancy and early in gestation were 31% less likely to have an infant shorter in length and 22% less likely to deliver an infant small for gestational age.

Panel: Post-Guatemala, US research safeguards adequate, but improvement needed

Panel: Post-Guatemala, US research safeguards adequate, but improvement needed

Current US rules and regulations provide substantial protections for the health, rights and welfare of participants of federally funded clinical trials and other research, but there is room for improvement, a panel of expert advisers to President Barack Obama said in a new report.

"Faulty" economic analysis results in preliminary NICE no for Novartis' DMO

"Faulty" economic analysis results in preliminary NICE no for Novartis' DMO

NICE, the health technology appraisal institute for England and Wales, has said a preliminary no to Novartis' Lucentis (ranibizumab) for patients with visual impairment due to diabetic macular oedema (DMO) for use on the National Health Service. The firm had presented a "faulty" economic analysis that failed to reflect UK clinical practice, said NICE.