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CDER to transition Office of Compliance to Super Office
The Center for Drug Evaluation and Research recently announced that it will elevate the Office of Compliance to a Super Office to continue to ensure the safety, quality, and integrity of drugs in America, according to a memo from CDER Director Janet Woodcock.
The Center for Drug Evaluation and Research (CDER) recently announced that it will elevate the Office of Compliance (OC) to a Super Office to continue to ensure the safety, quality, and integrity of drugs in America, according to a memo from CDER Director Janet Woodcock.
Deb Autor, who has lead OC for the past 5 years, will serve as acting director of the new Compliance Super Office. CDER/OC will house subordinate offices within its organizational structure, similar to other Super Offices. Three office-wide functions will be established in the Immediate Office including risk science, intelligence, and prioritization; policy and communication; and organizational strategy (strategic planning, organizational development, and QMS). Counterparts will be established in each sub-office. “These are key components of a high-functioning, policy-driven, risk-based organization, and their elevation and integration in the CDER/OC structure promises to help CDER/OC to continue to evolve and grow,” said Woodcock in the memo.
The responsibilities of the CDER/OC Super Office will include ensuring compliance with requirements relating to good manufacturing practice, good clinical practice, human subject protection, adverse event and drug quality reporting, REMS, drug labeling, drug approval, drug importation, and supply chain integrity, among many others, she added.
“The reorganization will enable Compliance to align its scientific, technical and legal capabilities with closely related program areas, leveraging our resources and maximizing its ability to achieve its public health mission,” Woodcock said.
The new structure will be as follows:
The Office of Compliance Super Office
Office of Drug Security, Integrity & Recalls
Division of Import Operations & Recalls
Recalls Coordination Branch
Import Operations Branch
Division of Supply Chain Integrity
Office of Manufacturing & Product Quality
Division of International Drug Quality
International Compliance Branch 1
International Compliance Branch 2
Division of Domestic Drug Quality
Domestic Compliance Branch 1
Domestic Compliance Branch 2
Division of Policy, Collaboration & Data Operations
Drug Surveillance and Data Reporting Branch
Regulatory Policy and Collaboration Branch
Division of Good Manufacturing Practice (GMP) Assessment
Biotech Manufacturing Assessment Branch
New Drug Manufacturing Assessment Branch
Generic Drug Manufacturing Assessment Branch
Office of Scientific Investigations
Division of Bioequivalence (BEQ) and Good Laboratory Practice (GLP) Compliance
Bioequivalence (BEQ) Branch
Good Laboratory Practice (GLP) Branch
Division of Good Clinical Practice (GCP) Compliance
GCP Enforcement Branch
GCP Assessment Branch
Division of Safety Compliance
Post Market Safety Branch
Human Subject Protection Branch
Office of Unapproved Drugs & Labeling Compliance
Division of Prescription Drugs
Prescription Drugs Branch
Compounding and Pharmacy Practices Branch
Division of Non-Prescription Drugs & Health Fraud
Over-the-Counter Drugs Branch
Health Fraud and Consumer Outreach Branch
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