FDA gene rules impractical

Understanding the new FDA pregnancy and lactation labeling rules☆

Dermatologists should be aware that the new Pregnancy and Lactation Labeling Rule (PLLR) has taken effect on June 30th, 2015. This mandate from the Federal Drug Administration (FDA) eliminated the standard pregnancy category letters for prescription medications (A, B, C, D and X). The new recommendations are now in the form of drug labeling that contains increased detail but also increased comp...

Proposed FDA rules on painkillers in U.S. Rile cancer community.

Undertreatment of cancer pain remains a substantial problem, according to a new survey conducted by the American Cancer Society. Published in May, the survey found that 65% of interviewees had moderate or severe pain. Now, an initiative from the U.S. Food and Drug Administration could make it even more diffi cult for cancer patients to get adequate pain relief by limiting access to opioids, acc...

Impractical CME programs: Influential parameters in Iran

Background: Traditional approaches in Continuing Medical Education (CME) appear to be ineffective in any improvement of the patients' care, reducing the medical errors, and/or altering physicians' behaviors. However, they are still executed by the CME providers, and are popular among the majority of the physicians. In this study, we aimed to explore the parameters involved in the degree of effe...

Critics call quality report changes impractical, pay updates unfair.

FDA Flags Inconsistent Hospital Reporting Of Medical Device Problems: Hazy Reporting Rules Beget Confusion.

The National Evaluation System for Health Technology will be developed over the next five years to upgrade and improve the reporting of medical device adverse events. However, participants using the new system will incur significant capital costs.