FDA clears a Spineart 510(k) for its Scarlet AC-Ti secured anterior cervical cage.
Teva says FDA should drop its recommendation for the use of dedicated manufacturing facilities for ezetimibe to prevent cross-contamination.
FDA publishes for comment the International Council for Harmonization M14 guidance on general principles for planning, designing, and analyzing pharma...
FDA accepts for priority review a Sanofi supplemental BLA for Sarclisa (isatuximab) in combination with standard of care for treating patients with tr...
FDA co-sponsors a 6/26-27 public workshop on using patient-generated health data in medical device development.
FDA publishes a draft guidance on the drug development platform technology designation program.
Federal Register notice: CDER proposes to withdraw approval of four NDAs after the application holders repeatedly failed to file required annual repor...
Federal Register notice: FDA issues a priority review voucher to Pfizer after determining that its Paxlovid tablets meet the criteria for a material t...
