Glossary | Plain English for the acronyms.

Healthcare fraud and compliance.

AKS: Anti-Kickback Statute, 42 U.S.C. § 1320a-7b(b). Federal criminal statute that prohibits exchange of remuneration for referrals of items or services payable by a federal healthcare program.
FCA: False Claims Act, 31 U.S.C. § 3729. Imposes civil and treble-damages liability on persons who knowingly submit false claims for payment to the federal government.
Stark: Physician Self-Referral Law, 42 U.S.C. § 1395nn. Prohibits physicians from referring Medicare patients to entities with which the physician has a financial relationship, subject to defined exceptions.
HIPAA: Health Insurance Portability and Accountability Act of 1996. Federal law governing privacy, security, and portability of protected health information.
OIG: Office of Inspector General, U.S. Department of Health and Human Services. The federal office that investigates fraud, waste, and abuse in federal healthcare programs and maintains the exclusion list.
LEIE: List of Excluded Individuals and Entities, maintained by the OIG. Persons on the LEIE are barred from participating in federal healthcare programs in any capacity.
DOJ: U.S. Department of Justice. Prosecutes federal criminal cases and brings civil enforcement actions.
USAO: U.S. Attorney's Office. The DOJ component that prosecutes federal cases in a particular judicial district.
CMS: Centers for Medicare and Medicaid Services. The federal agency that administers Medicare and Medicaid.

FDA and biologics.

BLA: Biologics License Application. The marketing authorization filing for a biologic product in the United States.
IND: Investigational New Drug application. The filing that permits a sponsor to ship an investigational product across state lines for use in human clinical trials.
351(a): Section 351(a) of the Public Health Service Act. The full BLA licensure pathway for new biologic products, requiring an IND and a clinical program before licensure.
351(k): Section 351(k) of the Public Health Service Act. The abbreviated licensure pathway for biosimilars referencing an existing 351(a) product.
21 CFR 1271: FDA regulation on Human Cells, Tissues, and Cellular and Tissue-Based Products. Governs registration, donor screening, and good tissue practice for HCT/P products.
21 CFR 312: FDA regulation on Investigational New Drug applications. Governs IND content, conduct, and reporting requirements.
CBER: Center for Biologics Evaluation and Research, FDA. The FDA center that reviews biologics including vaccines, blood products, gene therapies, and cell therapies.
CMC: Chemistry, Manufacturing, and Controls. The FDA review section covering product characterization, manufacturing, and quality control.
HCT/P: Human Cells, Tissues, and Cellular and Tissue-Based Products. The FDA regulatory category covering products of human origin intended for transplantation, transfer, or implantation.
RMAT: Regenerative Medicine Advanced Therapy designation. An expedited FDA designation for regenerative medicine products addressing unmet medical need.
Type B meeting: FDA pre-IND, end-of-phase, or pre-BLA meeting at scheduled milestones in product development.
Type C meeting: FDA meeting type for focused scientific exchange between sponsor and agency that does not fit Type A or Type B.

Litigation and federal courts.

MDL: Multidistrict Litigation. Federal procedural mechanism for consolidating pretrial proceedings of multiple civil cases sharing common questions.
JPML: Judicial Panel on Multidistrict Litigation. The federal panel that decides whether to consolidate cases under MDL procedures.
S.D.N.Y.: United States District Court for the Southern District of New York.
N.D. Cal.: United States District Court for the Northern District of California.
N.D. Tex.: United States District Court for the Northern District of Texas.

Plain English for the acronyms.

Healthcare fraud and compliance.

FDA and biologics.

Litigation and federal courts.

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