The Federal Drug Administration (FDA) Center for Drug Evaluation and Research (CDER) has issued a list of planned draft and final guidance documents for release in 2012. لعبة الكازينو There are about 50 such guidances planned. Below are a few select highlights relevant to the preclinical safety space, with emphasis on the drug development of small molecules. العاب تربح جوائز حقيقية
Electronic Submissions
- Providing Regulatory Submissions in Electronic Format – General Considerations
- Providing Regulatory Submissions in Electronic Format – Human Pharmaceutical Product Applications and Related Submissions. Using the eCTD Specifications
- Providing Regulatory Submissions in Electronic Format – Study Data
- Providing Regulatory Submissions in Electronic Format – Standardized Study Data
Procedural
- Integrated Summary of Safety
- Investigational New Drug (IND) Applications prepared and submitted by Clinical Sponsor Investigators