Regulatory Terms Starting With P

Paragraph IV

Paragraph IV helps teams standardize terminology and improve decision traceability.

PART 210

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

PART 211

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

PART 312

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

PART 314

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

PART 600

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

PART 820

PART 820 helps teams standardize terminology and improve decision traceability.

Periodic Benefit-Risk Evaluation Report (PBRER)

A periodic safety report format harmonized by ICH for presenting comprehensive benefit-risk analysis of medicinal products.

Periodic Safety Update Report (PSUR)

A periodic report summarizing the global safety profile of a marketed medicinal product.

Pharmaceuticals and Medical Devices Agency (PMDA)

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

Pharmacovigilance (PV)

The science and activities relating to the detection, assessment, understanding, and prevention of adverse drug reactions.

Phase 1 Clinical Trial (Phase 1)

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

Phase 2 Clinical Trial (Phase 2)

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

Phase 3 Clinical Trial (Phase 3)

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

Pivotal TRIAL

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

PMA Supplement

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

POST Approval STUDY

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

POST MARKET Clinical FOLLOW UP

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

POST MARKET Surveillance

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

PPQ (PPQ)

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

Pre-Submission Meeting (Pre-Sub)

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

Predicate

Predicate helps teams standardize terminology and improve decision traceability.

Premarket Approval (PMA)

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

Prescription Drug User Fee Act (PDUFA)

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

Priority Review (Priority)

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

Process Validation (PV)

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

Process Validation (PV)

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

Protocol Deviation

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