And finally another FDA Final Guidance for Industry
Providing Regulatory Submissions in Electronic Format-Submissions Under Section 745A(a) of the Federal Food, Drug, and Cosmetic Act
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Another FDA Final Guidance for Industry
Providing Regulatory Submissions In Electronic Format -Standardized Study Data
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FDAs Final Guidance for Industry
Patient Counseling Information Section of Labeling for Human Prescription Drug and Biological Products-Content and Format
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Season's Greetings!
The whole Widler & Schiemann Ltd. team wishes you happy holidays and a successful and prosperous new year 2015!
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Exception From Informed Consent Requirements for Emergency Research
This is a 17 Nov 2014 update from the previous MAPP version dated 4 Feb 2003
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