Draft Guidance for Industry and Investigators: Safety Reporting Requirements for Investigational New Drug Applications andBioavailability/Bioequivalence Studies; Availability

Document ID: FDA-2010-D-0482-0001

Comments

Total: 23
George C Phillips - Comment
Posted : 11/19/2010     ID :FDA-2010-D-0482-0002     Agency : FDA

Dec 28,2010 11:59 PM ET
Gilead Sciences, Inc. - Comment
Posted : 11/29/2010     ID :FDA-2010-D-0482-0003     Agency : FDA

Dec 28,2010 11:59 PM ET
Baxter Healthcare Corporation - Comment
Posted : 12/17/2010     ID :FDA-2010-D-0482-0004     Agency : FDA

Dec 28,2010 11:59 PM ET
PharmaNet - Comment
Posted : 12/21/2010     ID :FDA-2010-D-0482-0005     Agency : FDA

Dec 28,2010 11:59 PM ET
AstraZeneca - Comment
Posted : 12/21/2010     ID :FDA-2010-D-0482-0006     Agency : FDA

Dec 28,2010 11:59 PM ET
Association of Clinical Research Professionals - Comment
Posted : 12/21/2010     ID :FDA-2010-D-0482-0007     Agency : FDA

Dec 28,2010 11:59 PM ET
Merck & Co, Inc. - Comment
Posted : 12/21/2010     ID :FDA-2010-D-0482-0008     Agency : FDA

Dec 28,2010 11:59 PM ET
Bob Bader - Comment
Posted : 12/21/2010     ID :FDA-2010-D-0482-0009     Agency : FDA

Dec 28,2010 11:59 PM ET
Novo Nordisk Inc. - Comment
Posted : 12/21/2010     ID :FDA-2010-D-0482-0010     Agency : FDA

Dec 28,2010 11:59 PM ET
Novartis Pharmaceuticals - Comment
Posted : 12/21/2010     ID :FDA-2010-D-0482-0011     Agency : FDA

Dec 28,2010 11:59 PM ET
Amgen, Inc. - Comment
Posted : 12/23/2010     ID :FDA-2010-D-0482-0012     Agency : FDA

Dec 28,2010 11:59 PM ET
Consortium of Independent Review Boards (CIRB) - Comment
Posted : 12/27/2010     ID :FDA-2010-D-0482-0013     Agency : FDA

Dec 28,2010 11:59 PM ET
Johnson & Johnson Pharmaceutical Research & Development - Comment
Posted : 12/27/2010     ID :FDA-2010-D-0482-0014     Agency : FDA

Dec 28,2010 11:59 PM ET
Cancer Therapy Evaluation Program, DCTD, NCI - Comment
Posted : 12/27/2010     ID :FDA-2010-D-0482-0015     Agency : FDA

Dec 28,2010 11:59 PM ET
Bausch+Lomb - Comment
Posted : 12/28/2010     ID :FDA-2010-D-0482-0016     Agency : FDA

Dec 28,2010 11:59 PM ET
Abbott - Comment
Posted : 12/28/2010     ID :FDA-2010-D-0482-0017     Agency : FDA

Dec 28,2010 11:59 PM ET
Biotechnology Industry Organization (BIO) - Comment
Posted : 12/28/2010     ID :FDA-2010-D-0482-0018     Agency : FDA

Dec 28,2010 11:59 PM ET
Judith Mae Kramer - Comment
Posted : 12/29/2010     ID :FDA-2010-D-0482-0019     Agency : FDA

Dec 28,2010 11:59 PM ET
Elan Pharmaceuticals, Inc. - Comment
Posted : 01/21/2011     ID :FDA-2010-D-0482-0021     Agency : FDA

Dec 28,2010 11:59 PM ET
Pharmaceutical Research and Manufacturers of America - Comment
Posted : 01/21/2011     ID :FDA-2010-D-0482-0022     Agency : FDA

Dec 28,2010 11:59 PM ET
Johnson & Johnson Pharmaceutical Research & Development - Comment
Posted : 01/26/2011     ID :FDA-2010-D-0482-0023     Agency : FDA

Dec 28,2010 11:59 PM ET
Pharmaceutical Research and Manufacturers of America (PhRMA) - Comment
Posted : 01/26/2011     ID :FDA-2010-D-0482-0024     Agency : FDA

Dec 28,2010 11:59 PM ET
Pharmaceutical Research and Manufacturers of America (PhRMA) - Comment
Posted : 05/17/2011     ID :FDA-2010-D-0482-0028     Agency : FDA

Dec 28,2010 11:59 PM ET