FDA QMM 을 통한 의약품 제조시설 등급제 추진

아래 지난 4월, FDA meeting 에서 발표했던 QMM 과 관련된 백서(White paper) 의 내용을 보면 Quality 관리 성숙도 (Quality Management Maturity) 등급에 따라 제조업체에 Incentive 를 부여해야한다는 의견을 포함하고...

Quality Management System Regulation: Final Rule Amending the Quality System Reg - U.S. Food and Drug Adm....

The FDA amended the title of the Quality System Regulation, and established requirements that clarify certain expectations and concepts used in ISO 13485:2016. The revised part 820 is referred to a...

Quality System (QS) Regulation/Medical Device Current Good Manufacturing Practic - U.S. Food and Drug Adm....

Update: January 31, 2024 · The FDA issued the Quality Management System Regulation (QMSR) Final Rule to amend the device current good manufacturing practice (CGMP) requirements of the Quality System (QS) regulation (21 CFR Part 820), incorporating by reference the international standard specific for medical device quality management systems set by the International Organization for Standardization (ISO), ISO 13485:2016 Medical devices – Quality management systems – Requirements for regulatory purposes. This final rule is the latest action ...

US FDA Quality Metrics Technical Conformance Guide | PPT

Recommended for you ; Who Guidelines for Preparing SMF ; ANDA Stability Requirements ; Gsp china

Quality Metrics for Drug Manufacturing | FDA

Quality Metrics Data Reporting: This program will help FDA to address common quality issues in the pharmaceutical industry, address product shortage issues, and encourage modernization of pharmaceu...

Compounding Quality Center of Excellence | FDA - U.S. Food and Drug Administration

Compounded drugs pose unique risks to patients because they are not reviewed by the agency for safety, effectiveness or quality. The Center of Excellence FDA will explore new ways to engage and col...

CDER Quality Management Maturity | FDA - U.S. Food and Drug Administration

FDA has proposed the development of a rating system that will help incentivize drug manufacturers to achieve Quality Mangement Maturity at their facilities.

FDA Quality System Regulation for Medical Devices (21 CFR Part 820): A Practitio - 예스24

정가 : 25,290원, 판매가 : 20,730원 (18% 할인), YES포인트 : 1,040원 (5% 적립) + 마니아추가적립 · 5만원이상 구매 시 2천원 추가적립

eSTAR Program | FDA - U.S. Food and Drug Administration

Update: August 22, 2024 · The FDA issued final guidance on using the Electronic Submission Template (eSTAR) for submitting De Novo requests for medical devices. This guidance establishes an implementation date of October 1, 2025, for required use of eSTAR for De Novo submissions. eSTAR is now available for voluntary use for 513(g) requests for information to CBER.

Overview of Device Regulation | FDA - U.S. Food and Drug Administration

Establishment registration, ; Medical Device Listing, ; Premarket Notification 510(k), unless exempt, or Premarket Approval (PMA), ; Investigational Device Exemption (IDE) for clinical studies