Submission Terms (175)

FDA regulations governing electronic records and electronic signatures to ensure their trustworthiness and reliability.

505b1 supports cross-functional regulatory execution across quality, clinical, and safety teams.

505b2 helps teams standardize terminology and improve decision traceability.

505J helps teams standardize terminology and improve decision traceability.

A premarket submission demonstrating that a medical device is substantially equivalent to a legally marketed predicate device.

An application for FDA approval of a generic drug product that references an already-approved drug.

An FDA pathway allowing earlier approval based on surrogate or intermediate endpoints for serious conditions.

Accelerated Stability is used to prevent quality failures and strengthen manufacturing control strategy.

The substance in a pharmaceutical drug that is biologically active and produces the intended therapeutic effect.

Adaptive TRIAL DESIGN is an important device-regulatory concept for pathway selection, evidence strategy, and compliance.

Aggregate Reporting is a recurring concept across regulatory planning, compliance operations, and global submissions.

Analytical METHOD Validation is foundational for process control, product quality, and inspection-readiness in manufacturing.

ANDS helps teams standardize terminology and improve decision traceability.

ANNEX 11 supports cross-functional regulatory execution across quality, clinical, and safety teams.

A yearly report submitted to FDA summarizing changes and updates to an approved drug application.

Approval LETTER shapes how sponsors structure filings, amendments, and authority responses.

AUDIT TRAIL is used to support defensible premarket and postmarket device decisions.

A comprehensive document containing all information and instructions for manufacturing a specific batch of drug product.

Bioequivalence helps teams standardize terminology and improve decision traceability.

A submission to the FDA requesting approval to market a biological product in the United States.

Biosimilar is a recurring concept across regulatory planning, compliance operations, and global submissions.

An FDA designation for drugs showing substantial improvement over existing treatments for serious conditions.

Bridging STUDY supports cross-functional regulatory execution across quality, clinical, and safety teams.

Causality Assessment supports cross-functional regulatory execution across quality, clinical, and safety teams.

CDMO helps teams standardize terminology and improve decision traceability.

CBER is the FDA center responsible for regulating vaccines, blood products, and certain cellular and gene therapy products.

CDRH is the FDA center that regulates medical devices and radiation-emitting electronic products in the United States.

CDER is the FDA center responsible for evaluating and regulating prescription and over-the-counter human drugs in the United States.

Centralized Procedure is a recurring concept across regulatory planning, compliance operations, and global submissions.

CGMP is foundational for process control, product quality, and inspection-readiness in manufacturing.

CHANGE Control supports cross-functional regulatory execution across quality, clinical, and safety teams.

The section of a regulatory submission describing a drug's composition, manufacturing process, and quality controls.

CHMP supports cross-functional regulatory execution across quality, clinical, and safety teams.

CLASS II is a recurring concept across regulatory planning, compliance operations, and global submissions.

CLASS III is a recurring concept across regulatory planning, compliance operations, and global submissions.

Cleaning Validation is foundational for process control, product quality, and inspection-readiness in manufacturing.

Clinical Evaluation REPORT supports compliant clinical development and cleaner decision-making across trial phases.

Clinical HOLD is central to trial design quality, protocol execution, and evidence credibility.

Clinical STUDY REPORT helps teams align study conduct, data integrity, and regulator expectations.

Clinical TRIAL supports compliant clinical development and cleaner decision-making across trial phases.

Combination Product supports cross-functional regulatory execution across quality, clinical, and safety teams.

An internationally harmonized format for organizing pharmaceutical regulatory submissions into five standardized modules.

Companion Diagnostic is a recurring concept across regulatory planning, compliance operations, and global submissions.

Comparability Protocol is central to trial design quality, protocol execution, and evidence credibility.

An FDA letter indicating that an application review is complete but the application is not approved as submitted.

Confirmatory TRIAL is central to trial design quality, protocol execution, and evidence credibility.

Consent DECREE is central to trial design quality, protocol execution, and evidence credibility.

Container Closure SYSTEM is a recurring concept across regulatory planning, compliance operations, and global submissions.

Continued Process Verification supports cross-functional regulatory execution across quality, clinical, and safety teams.

A company that provides outsourced research services to pharmaceutical and biotechnology companies.

Control Strategy helps teams standardize terminology and improve decision traceability.

A systematic approach to identifying, investigating, and addressing the root causes of quality problems.

CQA is foundational for process control, product quality, and inspection-readiness in manufacturing.

Critical Process Parameter supports cross-functional regulatory execution across quality, clinical, and safety teams.

Critical Quality Attribute is used to prevent quality failures and strengthen manufacturing control strategy.

CSV helps teams standardize terminology and improve decision traceability.

The completeness, consistency, and accuracy of data throughout its lifecycle, following ALCOA+ principles.

DATA Monitoring Committee is central to trial design quality, protocol execution, and evidence credibility.

A pathway for novel low-to-moderate risk medical devices that lack a predicate but do not require PMA-level review.

Deficiency LETTER supports cross-functional regulatory execution across quality, clinical, and safety teams.

Systematic practices applied during product design and development to ensure devices meet user needs and intended uses.

DESIGN SPACE is used to support defensible premarket and postmarket device decisions.

A departure from an approved procedure, specification, or established standard during manufacturing or testing.

DEVICE History RECORD is used to support defensible premarket and postmarket device decisions.

DEVICE MASTER RECORD is used to support defensible premarket and postmarket device decisions.

DHF is an important device-regulatory concept for pathway selection, evidence strategy, and compliance.

Disproportionality helps teams standardize terminology and improve decision traceability.

A confidential document submitted to FDA containing detailed information about manufacturing facilities, processes, or components.

DRUG Product helps teams standardize terminology and improve decision traceability.

DRUG Substance helps teams standardize terminology and improve decision traceability.

E6 GCP is a recurring concept across regulatory planning, compliance operations, and global submissions.

A standardized electronic format for organizing and submitting regulatory applications to health authorities worldwide.

Electronic DATA Capture supports cross-functional regulatory execution across quality, clinical, and safety teams.

Electronic Signature is a recurring concept across regulatory planning, compliance operations, and global submissions.

Elemental Impurity supports robust CMC packages and defensible quality decisions during review.

END OF PHASE 2 Meeting is central to trial design quality, protocol execution, and evidence credibility.

Endpoint helps teams align study conduct, data integrity, and regulator expectations.

ETASU is a recurring concept across regulatory planning, compliance operations, and global submissions.

The European Union agency responsible for the scientific evaluation, supervision, and safety monitoring of medicines.

An inactive substance used as a carrier or vehicle for the active pharmaceutical ingredient in a drug product.

Expanded ACCESS helps teams standardize terminology and improve decision traceability.

Expedited Reporting supports cross-functional regulatory execution across quality, clinical, and safety teams.

Extractables AND Leachables is a recurring concept across regulatory planning, compliance operations, and global submissions.

An FDA program designed to facilitate development and expedite review of drugs treating serious conditions and filling unmet medical needs.

FIELD ALERT REPORT supports cross-functional regulatory execution across quality, clinical, and safety teams.

The US federal agency responsible for protecting public health by regulating food, drugs, biologics, medical devices, and cosmetics.

FORM 483 is a recurring concept across regulatory planning, compliance operations, and global submissions.

Genotoxic Impurity is foundational for process control, product quality, and inspection-readiness in manufacturing.

GLP helps teams standardize terminology and improve decision traceability.

International ethical and scientific quality standards for designing, conducting, and reporting clinical trials.

GOOD Documentation Practices supports cross-functional regulatory execution across quality, clinical, and safety teams.

Regulations ensuring pharmaceutical products are consistently produced and controlled according to quality standards.

GUDID is an important device-regulatory concept for pathway selection, evidence strategy, and compliance.

GXP helps teams standardize terminology and improve decision traceability.

Canada's federal department responsible for regulating drugs, medical devices, and other health products.

HPFB helps teams standardize terminology and improve decision traceability.

ICH Q10 is a recurring concept across regulatory planning, compliance operations, and global submissions.

ICH Q1a supports cross-functional regulatory execution across quality, clinical, and safety teams.

ICH Q8 helps teams standardize terminology and improve decision traceability.

ICH Q9 is a recurring concept across regulatory planning, compliance operations, and global submissions.

IDE is a recurring concept across regulatory planning, compliance operations, and global submissions.

IMPORT ALERT supports cross-functional regulatory execution across quality, clinical, and safety teams.

The process by which a research participant learns about and agrees to participate in a clinical trial after understanding the risks, benefits, and alternatives.

An independent committee that reviews and approves research involving human subjects to ensure ethical standards and participant protection.

Interim Analysis supports compliant clinical development and cleaner decision-making across trial phases.

A global organization that develops harmonized pharmaceutical guidelines to ensure drug quality, safety, and efficacy.

An application to the FDA to begin clinical trials of a new drug in humans.

Investigator Brochure helps teams standardize terminology and improve decision traceability.

ISO 13485 supports cross-functional regulatory execution across quality, clinical, and safety teams.

All written, printed, or graphic matter on or accompanying a drug or device, including the package insert and promotional materials.

MAA is a recurring concept across regulatory planning, compliance operations, and global submissions.

MARKET Exclusivity supports cross-functional regulatory execution across quality, clinical, and safety teams.

MAUDE is used to support defensible premarket and postmarket device decisions.

MEDDRA helps teams standardize terminology and improve decision traceability.

FDA mandatory reporting requirements for manufacturers and user facilities when medical devices may have caused or contributed to death or serious injury.

Medication GUIDE helps teams standardize terminology and improve decision traceability.

MODULE 1 shapes how sponsors structure filings, amendments, and authority responses.

MODULE 2 is a core concept in dossier strategy, review-cycle management, and agency communication.

MODULE 3 is used to improve submission readiness and reduce review-cycle friction.

MODULE 4 shapes how sponsors structure filings, amendments, and authority responses.

MODULE 5 is a core concept in dossier strategy, review-cycle management, and agency communication.

NDS supports cross-functional regulatory execution across quality, clinical, and safety teams.

A formal request to the FDA for approval to market a new pharmaceutical drug in the United States.

ORANGE BOOK is a recurring concept across regulatory planning, compliance operations, and global submissions.

A status granted to drugs intended to treat rare diseases affecting fewer than 200,000 people in the US.

A test result that falls outside the established acceptance criteria or specifications.

Paragraph IV helps teams standardize terminology and improve decision traceability.

21 CFR Part 210 provides general CGMP requirements for manufacturing, processing, packing, and holding of drug products.

21 CFR Part 211 specifies current good manufacturing practice requirements for finished pharmaceuticals.

21 CFR Part 312 governs Investigational New Drug applications and clinical study conduct for investigational drugs in the US.

21 CFR Part 314 defines submission and approval requirements for NDAs and ANDAs in the United States.

PART 600 supports cross-functional regulatory execution across quality, clinical, and safety teams.

PART 820 helps teams standardize terminology and improve decision traceability.

Japan's regulatory agency responsible for approving pharmaceuticals, medical devices, and regenerative products.

The first stage of clinical testing in humans, primarily assessing safety, tolerability, and pharmacokinetics.

Clinical trials evaluating a drug's efficacy and optimal dosing in patients with the target disease.

Large-scale pivotal trials that confirm a drug's efficacy and safety to support regulatory approval.

Pivotal TRIAL helps teams align study conduct, data integrity, and regulator expectations.

PMA Supplement is used to support defensible premarket and postmarket device decisions.

POST Approval STUDY is a core concept in dossier strategy, review-cycle management, and agency communication.

POST MARKET Clinical FOLLOW UP is central to trial design quality, protocol execution, and evidence credibility.

POST MARKET Surveillance supports cross-functional regulatory execution across quality, clinical, and safety teams.

PPQ is used to prevent quality failures and strengthen manufacturing control strategy.

A meeting with FDA to discuss regulatory questions before submitting a marketing application.

Predicate helps teams standardize terminology and improve decision traceability.

The FDA process for approving Class III high-risk medical devices based on clinical evidence of safety and effectiveness.

US legislation that allows the FDA to collect fees from drug manufacturers to fund the new drug approval process.

An FDA designation that reduces the review time for drugs treating serious conditions and providing significant improvement over available therapy.

Documented evidence establishing high confidence that a process consistently produces a product meeting specifications.

Documented evidence that a process consistently produces a product meeting predetermined specifications and quality attributes.

Protocol Deviation helps teams align study conduct, data integrity, and regulator expectations.

Q1 Stability is used to prevent quality failures and strengthen manufacturing control strategy.

QOS is a recurring concept across regulatory planning, compliance operations, and global submissions.

A systematic approach to pharmaceutical development that begins with predefined objectives and emphasizes product and process understanding.

FDA regulations governing the methods and facilities used in the manufacture of medical devices.

Randomization helps teams standardize terminology and improve decision traceability.

REAL WORLD DATA is a recurring concept across regulatory planning, compliance operations, and global submissions.

REAL WORLD Evidence is a recurring concept across regulatory planning, compliance operations, and global submissions.

RLD supports cross-functional regulatory execution across quality, clinical, and safety teams.

ROOT CAUSE Analysis helps teams standardize terminology and improve decision traceability.

SHELF LIFE supports cross-functional regulatory execution across quality, clinical, and safety teams.

Software AS A Medical DEVICE is used to support defensible premarket and postmarket device decisions.

SOURCE DATA Verification supports cross-functional regulatory execution across quality, clinical, and safety teams.

Special Controls helps teams standardize terminology and improve decision traceability.

Testing to determine how a drug product's quality changes over time under the influence of environmental factors.

Statistical Analysis PLAN supports compliant clinical development and cleaner decision-making across trial phases.

Substantial Equivalence supports cross-functional regulatory execution across quality, clinical, and safety teams.

Surrogate Endpoint is central to trial design quality, protocol execution, and evidence credibility.

Technical FILE helps teams standardize terminology and improve decision traceability.

Technology Transfer helps teams standardize terminology and improve decision traceability.

Australia's regulatory agency for therapeutic goods including prescription medicines, medical devices, and biologicals.

TYPE B Meeting is a core concept in dossier strategy, review-cycle management, and agency communication.

A system for identifying medical devices through their distribution and use using a unique numeric or alphanumeric code.

An official FDA notice of significant regulatory violations requiring prompt corrective action.

Whodrug supports cross-functional regulatory execution across quality, clinical, and safety teams.