Latest papers

Crotalidae polyvalent immune Fab: in patients with North American crotaline envenomation.

Monoclonal antibody therapy-associated neurological disorders.

Safety of rotavirus vaccines: postmarketing surveillance in the WHO Region of the Americas.

Comparative mortality associated with ziprasidone and olanzapine in real-world use among 18,154 patients with schizophrenia: The Ziprasidone Observational Study of Cardiac Outcomes (ZODIAC).

A phase IV observational multi-centre, open-label study on efficacy and safety of tolperisone 150 mg in patients with painful muscle spasm associated with degenerative or inflammatory diseases of the musculoskeletal system.

Informed by the European Union experience: what the United States can anticipate and learn from the European Union's regulatory approach to biosimilars.

Troubled children: diagnosing, treating, and attending to context. A Hastings Center special report.

Prevention of pneumococcal disease among infants and children - use of 13-valent pneumococcal conjugate vaccine and 23-valent pneumococcal polysaccharide vaccine - recommendations of the Advisory Committee on Immunization Practices (ACIP).

Surveillance and medical devices

Accelerated approval and possible withdrawal of midodrine.

[The drug use results survey of Adenoscan injection 60 mg].

Why the FDA can't protect the public

Advancing the science for active surveillance: rationale and design for the Observational Medical Outcomes Partnership.

Treatment of chronic hepatitis C with pegylated interferon and ribavirin in treatment-naive patients in 'true life': a plea in favor of independent postmarketing evaluations.

Adverse events following influenza A (H1N1) 2009 monovalent vaccines reported to the Vaccine Adverse Event Reporting System, United States, October 1, 2009–January 31, 2010

Sevoflurane and QTc Prolongation: An Interesting Observation, or a Clinically Significant Finding?

Scaling up HIV rapid testing in developing countries: comprehensive approach for implementing quality assurance.

Postmarket surveillance of Menicon Z rigid gas-permeable contact lenses for up to 30 days continuous wear in the United States.

Detection of rotavirus antigenemia in routinely obtained serum specimens to augment surveillance and vaccine effectiveness evaluations.

IOM advises FDA on ethics in postmarket safety trials.