CoreMed Corporation

2012.04.22: [Guidance for Industry] Guidance for Establishing Safety in First-in-Human Studies during Drug Development and Q&A documents (Published by MHLW 4/18/2012)

This Guidance and Q&A documents shows the framework of our basic concept to support the smooth t…more

2012.03.22: [Guidance for Industry] Size of Beads in Drug Products Labeled for Sprinkle (Published 2/28/20112 )

The recommendations in this guidance are based on literature on chewing and swallowing particle size…more

2012.02.18: [Guidance for Industry] Determining the Extent of Safety Data Collection Needed in Late Stage Premarket and Postapproval Clinical Investigations (Draft Guidance) (Published 2/9/2012 )

This guidance is intended to assist sponsors of clinical investigations in determining the amounts a…more

2012.02.11: FDA has just issued three draft guidance documents on biosimilar product development to assist industry in developing such products in the United States.

These three guidance documents provide the FDA’s current thinking on key scientific and regulatory f…more

Headquarters
Tsunenari Bldg., 2-1-21, Kitahama, Chuo-ku, Osaka 541-0041, Japan
(TEL）+81-(0)6-6221-1352
(FAX) +81-(0)6-6221-1357
Tokyo office
KN Nihonbashi Bldg., 4-8-17, Nihonbashi-Honcho, Chuo-ku, Tokyo 103-0023, Japan
(TEL) +81-(0)3-5205-2757
(FAX) +81-(0)3-5205-2758
US office
2111 Wilson Blvd., Suite 600, Arlington, VA 22201, U.S.A.
(TEL) +1-347-225-5264 (Cell)
(TEL) +1-703-351-5034
(FAX) +1-703-351-9292
CoreMed America, LLC
2111 Wilson Blvd., Suite 600, Arlington, VA 22201, U.S.A.
(TEL) +1-703-283-7661 (Cell)
(TEL) +1-703-351-5034
(FAX) +1-703-351-9292

CoreMed