What Bureaucracy? FDA & A Compliance ‘Super Office’

What Bureaucracy? FDA & A Compliance ‘Super Office’

June 7th, 2011 // 12:26 pm @

Faced with growing challenges in clinical trials, manufacturing and drug safety – among many other issues – the FDA has decided to elevate the Office of Compliance to a so-called Super Office on a par with others in the Center For Drug Evaluation and Research, such as the Office of New Drugs, the Office of Pharmaceutical Science and the Office of Surveillance and Epidemiology.

!

The responsibilities will include ensuring compliance with requirements for 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 others, according to a memo from CDER director Janet Woodcock.

And the new super compliance office will also have three officewide functions established in its so-called ‘Immediate Office,’ which is FDA-speak for its own nerve center operations. These functions include risk science, intelligence, and prioritization; policy and communication; and organizational strategy, which includes strategic planning. The acting director will Deborah Autor, who headed the compliance office for the past five years and helped oversee agency dealings with Johnson & Johnson during the recent manufacturing scandal that led to a consent decree.

For the curious, this is the new structure.

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


Subscribe Now

Testimonial

"ExpertBriefings.com always selects excellent speakers – some of the best I have ever heard. Their messages are direct, clear, timely, and relevant."

Anon A. Mouse

Featured Partner