Regulatory glossary · Dallas · MMXXVI

Plain English for the acronyms.

The FDA, HHS, OIG, BLA, IND, AKS, FCA, Stark, and class-action shorthand used across this network of sites, defined in plain English. Read a term here before you meet the acronym in a filing or a diligence memo.

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.

Andrew Jonathan Hillman

Dallas senior paralegal and healthcare compliance expert witness. Not an attorney.

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