Looking to clarify its expectations for manufacturer responses following inspections, the FDA earlier this year unveiled, for the first time, draft guidance on best practices for the industry when replying to the receipt of a Form 483.
FDA expectations create potential friction in new Form 483 response guidance
Latest from Blog
STAT+: Top lawmaker takes aim at doctor lobby, linking AMA’s billing codes to fraud fight
WASHINGTON — For decades, politicians have blamed the country’s biggest doctor lobby for some of the health care systems problems. Now it faces a new line of attack as Republicans portray their
Opinion: The cruise ship hantavirus outbreak is a warning sign to the U.S.
Three passengers are dead. Seven people are ill. The ship is anchored off Cape Verde, passengers cannot disembark, and the World Health Organization is coordinating the response. The suspected cause is hantavirus,
Supreme Court restores access to abortion pill mifepristone through telehealth, mail, and pharmacies
WASHINGTON — The Supreme Court on Monday restored broad access to the abortion pill mifepristone, blocking a lower-court ruling that had threatened to upend one of the main ways abortions are provided across the
Researchers urge study of paternal deaths, though a new paper finds fatherhood is protective
Maternal health is a known crisis in the U.S., where pregnant women and new mothers die at a rate several times higher than in comparable countries. In recent years, increased awareness of
What to know about hantavirus, the illness suspected in a cruise ship outbreak
ALBUQUERQUE, N.M. — A rodent-borne illness is suspected of causing an outbreak aboard a cruise ship that has killed three people and sickened others. The germ, called hantavirus, has been confirmed in one of