다른 뉴스레터 둘러보기
FDA 자료 Selection of the Appropriate Package Type Terms and Recommendations for Labeling Injectable Medical Products Packaged in Multiple-Dose, Single-Dose, and Single-Patient-Use Containers for Human Use Guidance for Industry | Citizen Petitions and Petitions for Stay of Action Subject to Section 505(q) of the Federal Food, Drug, and Cosmetic Act Guidance for Industry (PDF - 195KB)
매출 수십배 거뜬'...바이오기업에 쏠린 자금의 기대감 | 가격은 비싸고 제품은 많고…제네릭 제도 개선안에 관심↑ | 삼성, 20조 휴미라 바이오시밀러 미국 허가 신청
FDA 자료 Good Review Management Principles and Practices for New Drug Applications and Biologics License Applications | ANDA Submissions — Content and Format of Abbreviated New Drug Applications |
SK바이오사이언스, 수두백신 출시 | [제약계 소식통] 글로벌제약사, 국내 R&D 투자비용 5.9% 증가 | 4가 독감 백신 가격 ‘추락하는 것은 날개가 없다’
FDA 자료 Product Identifiers Under the Drug Supply Chain Security Act - Questions and Answers Guidance for Industry | Product Identifier Requirements Under the Drug Supply Chain Security Act – Compliance Policy Guidance for Industry (PDF)