FDA Panelists Slam Agency's Proposed Opioid Trial Design
Advisors said outcomes from an enriched enrollment study would not be broadly generalizable
Source: medpagetoday.com
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FDA Panel Gives Unanimous Thumbs Up to OTC Naloxone
Advisory committee members signalled unanimous approval for making naloxone nasal spray available over the counter so the drug can be more accessible to more people.
Source: medscape.com
Opioid Use in Early Pregnancy Not Tied to Most Birth Defects
Feb 15, 2021 FRIDAY, Feb. 12, 2021 (HealthDay News) — Opioid use in early pregnancy is associated with a small increase in risk for cleft palate but no increase in risk for most major congenital malformations, and macrolide use in pregnancy is not associated with increased risk for major birth defects in offspring, according to two studies published online Feb. 10 in The BMJ. Brian T. Bateman, M.D., from Brigham and Women’s Hospital in Boston, and colleagues examined the risks of first trimester exposure to prescription opioids for major congenital malformations. Data were included for 1...
Source: physiciansweekly.com