First administration of new drugs to human. 4. Safety and ethical problems.

Applying human cell and regenerative medicine technologies to efficacy and safety testing of new drugs

New approach to ensure safety-first culture.

Barb Farlow wishes she had asked more questions about her daughter Annie’s care. Born with the chromosome disorder Trisomy 13, Annie was only a few months old when she died in hospital of what her parents believe may have been a treatable respiratory condition. Months after Annie’s death, they learned that a doctor had placed a “do not resuscitate” order on her chart without their consent, and ...

Evolution of the Food and Drug Administration Approach to Liver Safety Assessment for New Drugs: Current Status and Challenges

Biosimilars are biological medicines, the active substances of which are highly similar to those of biologics that have already been authorized. As for any other medicine, the applicant of the biosimilar marketing authorization must submit a risk-management plan (RMP)/pharmacovigilance plan. The pharmacovigilance plan should take into account risks identified during product development, the pot...

Introducing educational package of safety (An educational tool to get familiar with drugs and drinks

This article has no abstract.

New ethical obligations accompany new HIV drugs, conference told.