| 616 |
FDA Gudiance for Industry: M10 Bioanalytical Method Validation and Study Sample Analysis |
2023-01-27 |
| 615 |
ICH Q13 Continuous Manufacturing of Drug Substances and Drug Products 발표 |
2023-01-17 |
| 614 |
FDA Guidance for Industry(draft): Delaying, Denying, Limiting, or Refusing Inspection |
2023-01-13 |
| 613 |
Contamination Control Strategy Guideline |
2022-12-21 |
| 612 |
IPEC-PQG GMP for Excipients |
2022-12-17 |
| 611 |
OECD의 GLP분야 Data Integrity Guidelines |
2022-11-19 |
| 610 |
EU GMP 등 개정 계획 |
2022-09-05 |
| 609 |
EU_Volume 4. Annex 1: Manufacture of Sterile Medicinal Products |
2022-08-26 |
| 608 |
FDA: Conducting Remote Regulatory Assessments(RRAs) Q&A |
2022-08-05 |
| 607 |
정말로 FDA승인을 받은 제품인가? |
2022-07-13 |
