FDA Regulatory Affairs
Latest Publications

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Published By Informa Healthcare

9781587160073, 9780203483657
Latest Documents Most Cited Documents Contributed Authors Related Sources Related Keywords

Good Clinical Practices

2003 ◽  
pp. 207-231
Author(s):  
Robert Buckley
Keyword(s):  
Clinical Practices

The Practice of Regulatory Affairs

2003 ◽  
pp. 303-320
Author(s):  
David Mantus
Keyword(s):  
Regulatory Affairs

Electronic Submissions

2003 ◽  
pp. 249-302
Author(s):  
Shylendra Kumar ◽  
Vah‚Äö Ghahraman

Good Manufacturing Practices (GMPs) and Enforcement Actions

2003 ◽  
pp. 233-248
Author(s):  
Catherine Hay ◽  
Florence Kaltovich
Keyword(s):  
Good Manufacturing Practices

The Development of Orphan Drugs

2003 ◽  
pp. 195-205
Author(s):  
Marlene Haffner
Keyword(s):  
Orphan Drugs

Meeting with the FDA

2003 ◽  
pp. 115-127
Author(s):  
Alberto Grignolo

Biologics

2003 ◽  
pp. 129-151
Author(s):  
James Kenimer ◽  
John Jessop

Regulatory Strategy

2003 ◽  
pp. 21-37
Author(s):  
Jacqueline Dombroski
Keyword(s):  
Regulatory Strategy
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