CBER delivered an Order to Cease Manufacturing of HCT / Ps On November 1, 2010. Arsenault wrote a letter On November 1, 2010, to Barbara Cassens and Mary Malarkey of the FDA, requesting a hearing in accordance with 21 C.F.R. SS 1271.440(e) and 21 c.f.r. SS 16. A hearing under Part 16 is required to determine, based on the content and credibility of the evidence.
Original Description:
Original Title
7 Nov 2011 Opposition to CBER Motion to Deny Hearing and for ASJ With Supporting Memo
CBER delivered an Order to Cease Manufacturing of HCT / Ps On November 1, 2010. Arsenault wrote a letter On November 1, 2010, to Barbara Cassens and Mary Malarkey of the FDA, requesting a hearing in accordance with 21 C.F.R. SS 1271.440(e) and 21 c.f.r. SS 16. A hearing under Part 16 is required to determine, based on the content and credibility of the evidence.
CBER delivered an Order to Cease Manufacturing of HCT / Ps On November 1, 2010. Arsenault wrote a letter On November 1, 2010, to Barbara Cassens and Mary Malarkey of the FDA, requesting a hearing in accordance with 21 C.F.R. SS 1271.440(e) and 21 c.f.r. SS 16. A hearing under Part 16 is required to determine, based on the content and credibility of the evidence.