US Regulatory Affairs Flashcards
Why is a global regulatory strategy important?
To maximise market reach and navigate differing regulatory processes across regions.
Name the ‘major’ regulatory agencies.
FDA (US), EMA (EU), PMDA (Japan).
List some ‘medium-sized’ regulators.
Canada, Australia, Brazil, China.
What are the FDA’s main responsibilities?
Ensuring safety, efficacy, and security of drugs and medical products; accelerating innovation; providing science-based health info.
What does CDER regulate?
Over-the-counter and prescription drugs.
What does CBER regulate?
Biologics such as blood products, vaccines, and gene therapies.
What does CDRH regulate?
Medical devices and radiation-emitting products.
What are PDUFA fees?
Fees paid by companies for FDA review services.
What is an IND application?
A submission to begin clinical trials in the US.
What are the key components of an IND?
Quality (CMC), Nonclinical, Clinical, Administrative.
What is the IND review period?
30 days; FDA may approve or issue a clinical hold.
How long does an IND remain active?
Until NDA/BLA approval; subsequent trials fall under it.
What is the difference between NDA and BLA?
NDA is for chemical drugs; BLA is for biologics.
What is the FDA’s PDUFA timeline?
180 days post-filing (6 months for priority review).
What are Type A, B, C, and D FDA meetings?
A: Critical issues (30 days), B: Milestones (60), C: General topics (75), D: Narrow-scope (50).
Name the FDA’s expedited approval programs.
Fast Track, Breakthrough Therapy, Accelerated Approval, Priority Review.
What does Breakthrough Therapy designation provide?
Fast Track benefits + intensive FDA guidance.
What are common post-marketing requirements?
Labelling updates, CMC changes, risk management plans.
What happens if post-marketing obligations are not met?
Regulatory warnings, product withdrawal, legal action.
What is the key takeaway about regulatory strategy?
It is dynamic and requires continuous planning and engagement with the FDA.
