FDA SADR Rule Would Expedite Congenital Anomaly Reports, FDAer Says
Executive Summary
FDA's proposed rule on the reporting of postmarketing adverse events would require that spontaneous reports of congenital anomalies always be expedited to the agency, FDA Pregnancy Labeling Task Force Project Manager Dianne Kennedy said Jan. 9.
You may also be interested in...
FDA Adverse Event Rule Halted At OMB By Administration Regulation Freeze
An FDA proposed rule on reporting postmarketing adverse events is being held up at the Office of Management & Budget while the Bush Administration reviews new and pending regulations.
FDA Adverse Event Rule Halted At OMB By Administration Regulation Freeze
An FDA proposed rule on reporting postmarketing adverse events is being held up at the Office of Management & Budget while the Bush Administration reviews new and pending regulations.
CDER Review Manager Search Continues: Acting Head Jolson Departs Agency
The search for a new acting Office of Review Management Director has begun as acting ORM Director Heidi Jolson, MD, prepares to leave the agency Jan. 26.