Drugs

OPQ Looks at Five Years of Success

Since its founding in 2015, the FDA Office of Pharmaceutical Quality (OPQ) has worked to “assure that all drugs marketed in the U.S. meet quality standards so that every dose is safe and effective, and free of contamination and defects.” In its 2019 annual report, OPQ says it has provided assessment, inspection, research, surveillance, and policy to support the quality oversight of drugs legally marketed in the U.S.

Standards and policies based on science and risk are the foundation of the quality assessment of drug applications, the report says. The OPQ laboratories in Maryland and Missouri conduct research to support the development of science-based quality policies and OPQ then implements the policies and prepares CDER guidance documents related to drug product quality.

Drug quality assessments cover (1) how an applicant designs, manufactures, and tests the active ingredients and final drug products; and (2) whether the proposed manufacturing facilities are appropriate and prepared for commercial manufacturing.

OPQ also continues to oversee the quality of marketed drugs through the entire drug lifecycle. And it monitors the state of quality for all regulated manufacturing sites and drug products. “When used collectively, FDA’s regulatory tools give us high confidence in the quality of the U.S. drug supply,” the report says.

The report says the last five years have brought some significant challenges to OPA, including an unprecedented number of regulatory submissions, new user fee programs, urgent public inquiries, natural disasters, scientific advancements, and newly uncovered patient risks. To continue meeting the challenges of the future, the report says, OPQ has identified the priorities to work better together — to collaborate to encourage innovation; to innovate to educate about the importance of quality; to communicate; to engage to foster productive relationships with the public.

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome