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FDA: 2020년 CDER Guidance 작업 계획 발표

한국이엠에스
2020-02-26
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Guidance Agenda New & Revised Draft Guidances: CDER Plans to Publish During Calendar Year 2020

1월 30일 FDA가 발표한 바에 따르면 금년 CDER의 Guidance 제/개정 작업 계획은 14 카테고리 89개 문서이다.

GMP 와 관련된 카테고리는 Pharmaceutical Quality/CMC, Pharmaceutical Quality CGMP 그리고Pharmaceutical Quality/Microbiology인데 중요 의약품 GMP관련 문서는 다음과 같다.


Pharmaceutical Quality CGMP

  • PET Drugs - Current Good Manufacturing Practice (CGMP); Revised Draft

Pharmaceutical Quality/CMC

  • Cannabis and Cannabis-Derived Compounds: Quality Considerations for Clinical Research
  • Chemistry Manufacturing and Controls Considerations for Individualize Antisense Oligonucleotide (ASO) Therapies
  • Drug Products Administered Via Enteral Feeding Tube: In Vitro Testing and Labeling Recommendations
  • ICH Q12, General Considerations for FDA Implementation
  • Quality and Stability Testing of Drug Substances and Drug Products for NDAs, ANDAs, and BLAs and Associated Labeling Statements for Drug Products
  • Risk Management Plans to Mitigate the Potential for Drug Shortages
  • The Use of Physiologically Based Pharmacokinetic Analyses — Biopharmaceutics Applications for Oral Drug Product Development, Manufacturing Changes, and Controls

Pharmaceutical Quality/Microbiology

  • Microbiological Quality Considerations in Non-Sterile Drug Product Manufacturing

CDER 원문은 https://www.fda.gov/media/134778/download에서 볼 수 있다.

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CONTACT


대표자 : 이상건 | 사업자등록번호 : 454-81-00389

주소 : 경기도 안양시 동안구 경수대로651번길 58-2,

1층 (호계동)

Tel : 031-386-9433 | Fax : 031-386-9436

E-mail : hk@hkems.co.kr