Federal Register notice: FDA seeks comments on an information collection extension entitled Medical Device Recall Authority 21 CFR part 810 (OMB Cont...
FDA sends Acadia Pharmaceuticals a complete response letter on its supplemental NDA for Nuplazid (pimavanserin) for treating hallucinations and delusi...
FDA Review posts the Federal Register notices for the week ending 4/2/2020.
Federal Register notice: FDA determines for patent extension purposes the regulatory review period for Ardelyxs Ibsrela (tenapanor hydrochloride), ind...
Federal Register notice: FDA amends the animal drug regulations to reflect application-related actions for new animal drug applications and abbreviate...
FDA permits two Moderna Covid-19 revisions regarding the number of doses per vial available.
Allarity Therapeutics files a PMA for DRP-Dovitinib, the company's validated companion diagnostic for Novartis dovitinib that is intended to be used t...
FDA acting commissioner Janet Woodcock identifies five key activities the agency experienced during the Covid-19 pandemic that will be expanded or con...