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FDA to Launch New Office of Pharmaceutical Quality

The U.S. Food and Drug Administration (FDA) plans to launch a new office in 2015.  This new Office of Pharmaceutical Quality (OPQ) will be dedicated to ensuring that quality medicines are available to U.S. citizens.  According to the OPQ webpage, OPQ will create a uniform drug quality program across all domestic and foreign sites of manufacture and across all drug product areas.

OPQ was proposed in September 2012 by Janet Woodcock, director of FDA’s Center for Drug Evaluation and Research (CDER), who will serve as the acting director of OPQ.  In a statement to CDER staff, Woodcock said the new office would help “provide better alignment among all drug quality functions at CDER, including review, inspection, and research.”

Woodcock will be joined in leadership by Deputy Director Lawrence Yu, and many others from currently existing FDA offices:

  • Office of Program and Regulatory Operations (OPRO): Giuseppe Randazzo (Acting)
  • Office of Policy for Pharmaceutical Quality (OPPQ): Ashley Boam (Acting)
  • Office of Biotechnology Products (OBP): Director: Steve Kozlowski
  • Office of New Drug Products (ONDP): Sarah Pope Miksinski (Acting)
  • Office of Lifecycle Drug Products (OLDP): Susan Rosencrance (Acting)
  • Office of Testing and Research (OTR): Lucinda (Cindy) Buhse (Acting)
  • Office of Process and Facilities (OPF): Christine Moore (Acting)
  • Office of Surveillance (OS): Theresa Mullin (Acting)

Registrar Corp, an FDA compliance firm, stays up to date on FDA news and will keep readers posted as the new OPQ office unfolds.  Should you need any assistance with registering, listing, or labeling drug products, Registrar Corp can help.  Contact us at 1-757-224-0177 or receive Live Help from our regulatory specialists: http://www.registrarcorp.com/livehelp.





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