FDA accepts for priority review two Melinta Therapeutics NDAs for intravenous and oral Baxdela (delafloxacin) for treating patients with acute bacteri...
FDA clears a Luminex 510(k) for the Aries Group B Streptococcus (GBS) Assay for antepartum detection of GBS colonization in pregnant women.
Harvard professors Aaron Kesselheim and Jerry Avorn voice concern about some provisions of the 21st Century Cures Act that put expediency ahead of sci...
Lilly suggests improvements to a proposed FDA study on communicating prescription drug risk information in online character-space-limited formats.
CDRH asks for comment on lists of guidances it expects to publish in FY 2017 and finalized guidances from earlier years that should be revised or with...
CDRH director Jeffrey Shuren says that an agency safety communication cautioning against ovarian screening tests for asymptomatic women does not apply...
Attorney Allyson Mullen says FDA appears to have changed the focus of its now final guidance on medical device cybersecurity management.
Acorda asks FDA to carefully review ANDAs for generic Ampyra to ensure that impurities are properly identified and qualified.