jueves, 1 de marzo de 2018

OPQ Issues Annual Report for 2017

OPQ Issues Annual Report for 2017
The Office of Pharmaceutical Quality (OPQ) serves the public health through our
mission of assuring the availability of quality medicines for the American public. 
Our organization focuses on quality, which fundamentally supports the pharmaceutical 
pillars of safety and efficacy. Quality is what assures that drugs safely and reproducibly 
deliver the intended benefit claimed in their label, over their lifecycle. It is what gives 
the American public confidence in the safety and efficacy of their next dose of medicine.
OPQ has published its first public annual report which describes our accomplishments
in 2017. OPQ occupies a unique space at the U.S. Food and Drug Administration (FDA) 
by reaching across all human drug User Fee programs: new drugs and biologics, generics, 
and biosimilars – and also over-the-counter drugs and compounded drug products. Further, 
we reach across the drug product lifecycle including development, premarket, and 
postmarket. Many drugs are currently available to patients and consumers 
due to OPQ accomplishments across assessment, inspection, surveillance, policy,
and research.
I look forward to continuing and growing our contribution to global pharmaceutical quality
in 2018. We will do this, in part, by working with our business partners and stakeholders to 
enhance the FDA's pharmaceutical quality programs. It is our shared goal to assure the 
American public has access to safe, effective, quality medicines.
Michael Kopcha, Ph.D., R.Ph.
Director, Office of Pharmaceutical Quality

No hay comentarios: