FDA warns Medline, Inc., about CGMP violations in its manufacturing of drugs at its Waukegan, IL, facility.
FDA orders Takeda Pharmaceuticals to strengthen the safety labeling for its rare disease therapy Adzynma, including the addition of a Boxed Warning, after the agency and the company failed to reach agreement on how to address concerns about potentially life-threatening immune reactions.
FDA warns Medline, Inc., about CGMP violations in its manufacturing of drugs at its Waukegan, IL, facility.
FDA orders Takeda Pharmaceuticals to strengthen the safety labeling for its rare disease therapy Adzynma, including the addition of a Boxed Warning, after the agency and the company failed to reach agreement on how to address concerns about potentially life-threatening immune reactions.
FDA publishes a draft question-and-answer guidance on manufacturer communication of health care economic information to payors.
Former FDAer Peter Pitts says the agency must become more consistent in its application of innovative review methods to keep pace with changes in contemporary biomedical science.
