FDA News & Notes – Week of Nov. 28, 2016
Science, public health, and regulatory highlights from the U.S. Food and Drug Administration. Information in this document is designed for credentialed journalists. Release dates and times for items are current as of Nov. 28, 2016. Times listed are local time.
FDA News & Notes does not contain any regulatory or enforcement actions due to legal limitations.
In Case You Missed It:
Wednesday, 11/23 –
Revised Draft Guidance: Submission of Quality Metrics Data Guidance for Industry
. This initiates a voluntary phase of a quality metrics reporting program intended to help the FDA learn more about a limited set of quality metrics and associated analytics and improve the program. The FDA envisions using data from the quality metrics reporting program as an important factor in focusing the use of resources on the areas of highest risk to public health. When a quality metrics program is fully implemented, the agency may use these data to establish a signal detection program as one factor in identifying establishments and products that may pose significant risk to consumers; to identify situations in which there may be a risk for drug supply disruption; to improve the effectiveness of establishment inspections; and to improve the FDA’s evaluation of drug manufacturing and control operations.
Monday, 11/21 –
Consumer Health Information: What to Ask Your Doctor Before Taking Opioids
. Every patient should ask questions when getting a new prescription. This is especially important when your doctor, dentist or other health care professional prescribes you an opioid, such as hydrocodone, oxycodone, codeine and morphine.
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