Regulatory Affairs and Compliance
What this domain tests
This section covers approval pathways, labelling, and the line between permissible scientific exchange and prohibited promotion, plus the anti-corruption rules that shape field activities.
Core rules
- US pathways: IND; NDA under 505(b)(1) (own full data) or 505(b)(2) (reliance on literature or another's findings); BLA for biologics; ANDA for generics. Expedited tools include Fast Track, Breakthrough Therapy, Priority Review, Accelerated Approval (surrogate endpoint plus confirmatory trial) and Orphan designation with seven-year exclusivity.
- EU: centralized procedure through EMA/CHMP; conditional marketing authorisation; PRIME for priority medicines.
- Labelling: US Prescribing Information with boxed warnings and accompanying Important Safety Information; EU SmPC. Promotion must be consistent with the label, fair and balanced, and substantiated; pre-approval promotion is prohibited.
- Scientific exchange: companies may respond to unsolicited requests for off-label information and engage in genuine scientific exchange, but may not proactively promote unapproved uses.
- Compliance framework: Anti-Kickback Statute, False Claims Act, FCPA and UK Bribery Act, PhRMA/EFPIA/IFPMA codes, Open Payments, GDPR and HIPAA.
Worked example
At a congress an MSL is asked whether a drug works in adolescents although the label covers adults only. The correct response is a balanced, non-promotional answer grounded in the label and published literature, documented, with the unsolicited nature of the request recorded - not a recommendation to use the product, and not a referral to sales.
Traps that cost marks
- Believing off-label discussion is banned outright; it is unbridled promotion that is banned.
- Assuming FDA pre-approves promotional materials (routine pre-clearance does not exist outside specific contexts).
- Ignoring that an educational grant tied to prescribing is a kickback risk.