FDA Regulatory Glossary

Everything pharma BD teams need to know about FDA drug approval pathways, expedited programs, and regulatory processes. Each term includes definitions, recent examples, and business context.

50 Terms

4 Categories

Application Pathways

FDA drug approval application types and submission processes

505(b)(1)

505(b)(1) is the FDA's traditional full NDA pathway for new drugs. Learn about requirements, timeline, costs, and when t...

505(b)(2)

505(b)(2) is an FDA pathway for new drugs using prior approval data. Learn requirements, benefits, timeline, and recent ...

ANDA

ANDA (Abbreviated New Drug Application) is the FDA pathway for generic drug approval. Learn about 505(j) requirements, b...

Approval Letter

An FDA Approval Letter grants permission to market a drug in the United States. Learn what approval means and what comes...

BLA

BLA (Biologics License Application) is the FDA submission for biologic drug approval. Learn about BLA requirements, proc...

Complete Response Letter

A Complete Response Letter (CRL) is FDA's notice that an application cannot be approved in its current form. Learn about...

FDA Meeting Types

FDA meeting types (A, B, C) define the priority and timeline for sponsor-FDA consultations. Learn when to request each t...

IND

IND (Investigational New Drug) is the FDA application to begin human clinical trials. Learn about IND requirements, type...

NDA

NDA (New Drug Application) is the FDA submission requesting approval to market a new drug. Learn about NDA requirements,...

Orange Book

The Orange Book is FDA's official list of approved drug products with therapeutic equivalence evaluations. Essential for...

Pre-IND Meeting

A Pre-IND meeting is an FDA consultation before submitting an IND application. Learn about meeting types, preparation, a...

Refuse to File

Refuse to File (RTF) is FDA's decision that an application is too incomplete for substantive review. Learn about RTF cri...

Rolling Submission

Rolling submission allows sponsors to submit NDA/BLA sections as completed rather than waiting for the full package. Lea...

sBLA

sBLA (Supplemental BLA) is an FDA submission for changes to approved biologics. Learn about sBLA requirements, types, an...

sNDA

sNDA (Supplemental NDA) is an FDA submission for post-approval changes to approved drugs. Learn about sNDA types, requir...

Expedited Programs

FDA programs to accelerate drug development and review

Accelerated Approval

Accelerated Approval allows FDA to approve drugs based on surrogate endpoints before clinical benefit is confirmed. Lear...

Breakthrough Therapy

Breakthrough Therapy is an FDA designation for drugs showing substantial improvement over existing treatments. Learn abo...

Fast Track Designation

Fast Track is an FDA program to expedite development of drugs for serious conditions. Learn about eligibility, benefits,...

Orphan Drug Designation

Orphan Drug Designation provides incentives for developing drugs for rare diseases affecting fewer than 200,000 American...

PDUFA Date

PDUFA date is FDA's target decision deadline for drug applications. Learn about PDUFA timelines, extensions, and what ha...

Priority Review

Priority Review is an FDA designation providing a 6-month review timeline instead of standard 10 months. Learn about eli...

Priority Review Voucher

Priority Review Vouchers are transferable FDA incentives worth $100-350M that grant 6-month review for any drug. Learn a...

Project Orbis

Project Orbis is FDA's international collaboration for concurrent review of oncology drugs with partner agencies. Learn ...

QIDP

QIDP designation provides incentives for developing new antibiotics and antifungals. Learn about eligibility, benefits, ...

Rare Pediatric Disease Designation

Rare Pediatric Disease designation makes drugs eligible for Priority Review Vouchers upon approval. Learn about eligibil...

Real-Time Oncology Review

RTOR is an FDA pilot program for faster review of cancer drugs using real-time data submission. Learn about eligibility ...

RMAT

RMAT designation expedites development of regenerative medicines including gene therapies, cell therapies, and tissue pr...

Exclusivity & Patents

Market protection and intellectual property in pharma

180-Day Exclusivity

180-day exclusivity is market protection for the first generic filer with a successful Paragraph IV certification. Learn...

Authorized Generic

An authorized generic is a brand company's own generic version of its drug, sold alongside or competing with independent...

Data Exclusivity

Data exclusivity prevents FDA from using innovator clinical data to approve generics for a set period. Learn about types...

NCE Exclusivity

NCE (New Chemical Entity) exclusivity provides 5 years of market protection for novel drugs. Learn about eligibility, ti...

Orphan Drug Exclusivity

Orphan Drug exclusivity provides 7 years of market protection for drugs treating rare diseases. Learn about eligibility,...

Paragraph IV Certification

Paragraph IV certification is a generic company's challenge that brand patents are invalid or not infringed. Learn about...

Patent Linkage

Patent linkage connects patent rights to FDA regulatory approval, preventing generic approval before patent issues are r...

Patent Term Extension

Patent Term Extension (PTE) restores patent time lost during FDA review. Learn about eligibility, calculation, and maxim...

Pediatric Exclusivity

Pediatric exclusivity adds 6 months to existing patents and exclusivity for completing FDA-requested pediatric studies. ...

Regulatory Exclusivity

Regulatory exclusivity is FDA-granted market protection independent of patents. Learn about types, durations, and how ex...

Regulatory Process

Clinical and manufacturing standards for drug approval

Bioequivalence

Bioequivalence demonstrates that a generic drug performs identically to the brand version. Learn about BE studies, crite...

Clinical Hold

A clinical hold is an FDA order to suspend or delay a clinical trial due to safety concerns. Learn about clinical hold t...

CTD Format

CTD (Common Technical Document) is the standardized format for drug application submissions globally. Learn about CTD mo...

Drug Master File

A Drug Master File is a confidential FDA submission containing detailed manufacturing information. Learn about DMF types...

eCTD

eCTD is the mandatory electronic format for FDA drug submissions. Learn about eCTD requirements, structure, and submissi...

FDA Advisory Committee

FDA Advisory Committees are expert panels providing recommendations on drug approvals. Learn about AdCom meetings, votin...

FDA Inspection

FDA inspections verify compliance with GMP and GCP requirements at manufacturing sites and clinical trial sites. Learn a...

GMP

GMP (Good Manufacturing Practice) ensures drugs are consistently produced and controlled to quality standards. Learn abo...

Post-Marketing Commitment

Post-marketing commitments are studies a drug sponsor agrees to conduct after FDA approval. Learn about PMCs, PMRs, and ...

Reference Listed Drug

Reference Listed Drug is the FDA-approved product that generics must match for bioequivalence. Learn about RLD selection...

REMS

REMS is an FDA-required safety program ensuring a drug's benefits outweigh its risks. Learn about REMS elements and impl...

Surrogate Endpoint

A surrogate endpoint is a biomarker used instead of clinical outcomes to measure drug effect. Learn about surrogate endp...

Therapeutic Equivalence

Therapeutic equivalence means drugs can be substituted with the same clinical effect and safety. Learn about TE codes an...

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