IFDA
IND, NDA, BLA, ANDA, 510(k), De Novo or PMA, plus the meeting calendar and the warning-letter response. CDER approved 46 novel drugs in 2025 (FDA). CDRH authorized 124 novel devices in 2025 (FDA). FDA's QMSR took effect on February 2, 2026.
IILicensing
Collaboration, option, co-development and supply. Milestones, pharmacovigilance, manufacturing, territory and the change-of-control clause. This is not a customer contract with a science schedule attached.
IIIIP and exclusivity
Orange Book listings. FDA: NCE exclusivity 5 years, new clinical investigation 3 years, orphan-drug exclusivity 7 years, patent term 20 years from filing. Reference-product exclusivity is 12 years (FDA, Purple Book).
IVCompliance
Anti-kickback, off-label promotion, pricing, and False Claims Act exposure. DOJ, January 16, 2026: FCA settlements and judgments exceeded $6.8 billion in fiscal 2025, over $5.7 billion of it in health care. An independent CCO is a different search.
FDA is the file that disqualifies a generalist fastest. In 2025 the Center for Drug Evaluation and Research approved 46 novel drugs never before approved or marketed in the United States: 34 new molecular entities and 12 biologics. Exactly half, 23 of 46, received orphan-drug designation, and 32 of 46 were approved in the United States before any other country (FDA, Advancing Health Through Innovation: New Drug Therapy Approvals 2025). On the device side, the Center for Devices and Radiological Health authorized 124 novel medical devices in 2025, including 44 breakthrough devices that received marketing authorization (CDRH 2025 annual report). A GC who cannot read a complete-response letter, a refuse-to-file, or a 510(k) additional-information request is not the officer.
Device quality changed on a date the board can point to. FDA's Quality Management System Regulation took effect on February 2, 2026, amending 21 CFR Part 820 (Federal Register, February 2, 2024). A medtech succession briefed in 2026 that still describes the old Quality System Regulation as the current rule is already late. The person who owned that cutover is a different candidate from a pharma GC who has only lived drug GMP.
Licensing is the second disqualifier. The paper allocates development cost, diligence standards, know-how, manufacturing release, pharmacovigilance, and the economics if the asset is sold. A counsel who has only negotiated revenue contracts will treat the license as a long services agreement. We ask for the last license the candidate personally negotiated: parties by type, stage of the asset, and whether they held the pen or reviewed outside counsel's draft. Reviewing is not the same seat.
Intellectual property, for this officer, is exclusivity strategy rather than prosecution. FDA states that new chemical entity exclusivity lasts 5 years, new clinical investigation exclusivity 3 years, orphan-drug exclusivity 7 years, and a patent challenge by a first ANDA applicant 180 days. A new patent term is 20 years from the U.S. filing date (FDA, Patents and Exclusivity, current agency FAQ). For biologics, reference-product exclusivity runs 12 years from first licensure before a biosimilar approval can be made effective (FDA, Purple Book reference-product exclusivity). Patent information for the Orange Book is due on Form FDA 3542 within 30 days of NDA approval. The GC does not have to be the patent prosecutor. The GC does have to know which date keeps the product alone on the market, and when to call the prosecutor.
Compliance is the file that splits the search. The Department of Justice announced on January 16, 2026 that False Claims Act settlements and judgments exceeded $6.8 billion in the fiscal year ending September 30, 2025, and that over $5.7 billion related to the health care industry (DOJ Office of Public Affairs). Association of Corporate Counsel data from the 2026 Chief Legal Officers Survey, fielded September 10 to November 7, 2025, puts majority oversight of compliance at 64 percent of CLOs, and a direct report to the chief executive at 84 percent (1,049 CLOs, 20 industries, 43 countries). In life sciences those two facts collide: the GC often has the compliance book, and a corporate integrity agreement or a Medicare-heavy revenue line may require a compliance officer the GC does not supervise. We say which search you are in during week 1. The independent officer is a chief compliance officer search, inside 41 compliance-leadership placements since 2017, not a GC search with a policy manual attached.
