Attorney Adrienne Lenz says there are several provisions that should appeal to industry in an FDA final guidance on least burdensome approaches.
FDA issues a draft guidance seeking comment on a proposed CDER program issue a list of recognized voluntary consensus standards related to drug qualit...
Federal Register notice: FDA issues an Emergency Use Authorization (EUA) for a Chembio Diagnostic Systems in vitro diagnostic device for detecting Ebo...
FDA releases an FDA-483 with six observations issued following an inspection at Indias Indoco Remedies.
Federal Register notice: FDA determines the regulatory review period for MSD Italias Zejula (niraparib).
FDA sends LC Medical Concepts a Warning Letter after an inspection of the firms Rochester, NY, medical device operations found GMP concerns with the m...
FDA warns Akorn about CGMP violations at its Decatur, IL, drug manufacturing facility.
Federal Register notice: FDA seeks comments on an information collection extension entitled Safety Labeling Changes Implementation of Section 505(o)(...