Regulatory Terms Starting With P

26 terms in the P index.

• Patient Narrative (Patient Narrative)

  A patient narrative is the case-level prose account of one trial subject's death, serious adverse event, or other significant adverse event, written for the clinical study report rather than for expedited safety reporting.

• Patient-Reported Outcome (PRO)

  Patient-reported outcome (PRO) is an outcome measure captured directly from the patient about their own symptoms, function, or health status, with no interpretation, filtering, or amendment by a clinician, caregiver, or investigator.

• PDUFA (Prescription Drug User Fee Act)

  PDUFA is the US statute authorizing FDA to collect user fees from human drug and biologic sponsors, tying that revenue to negotiated review performance goals that produce the target action date known as the PDUFA date.

• Pediatric Exclusivity (Pediatric Exclusivity)

  Pediatric exclusivity is a six-month extension of a drug's existing FDA exclusivity and patent-based approval bars, earned by completing the pediatric studies FDA specified in a Written Request under FD&C Act section 505A.

• Pediatric Investigation Plan (PIP)

  A Pediatric Investigation Plan is the EU development programme for studying a medicine in children, assessed by EMA's Paediatric Committee. Marketing authorisation applications for new medicines must report results from an agreed PIP unless a waiver or deferral applies.

• Pediatric Study Plan (PSP)

  Pediatric Study Plan is the FDA-agreed development document a sponsor submits before its NDA or BLA, outlining the pediatric studies it will run, their age groups and endpoints, and any deferral or waiver request.

• Periodic Benefit-Risk Evaluation Report (PBRER)

  The Periodic Benefit-Risk Evaluation Report (PBRER) is the ICH E2C(R2) periodic safety report for marketed medicines, distinguished from the earlier PSUR format by a formal evaluation of benefit alongside risk to support an explicit benefit-risk conclusion.

• Periodic Safety Update Report (PSUR)

  Periodic Safety Update Report is a pharmacovigilance document a marketing authorisation holder submits at fixed intervals to re-evaluate an authorised medicine's benefit-risk balance against the safety data accumulated worldwide since the previous report.

• Pharmacodynamics (PD)

  Pharmacodynamics is the branch of clinical pharmacology that quantifies what a drug does to the body: target engagement, biochemical effect, and clinical response, measured against dose and blood concentration rather than the body's handling of the drug.

• Pharmacokinetics (PK)

  Pharmacokinetics is the quantitative description of what the body does to a drug over time: absorption, distribution, metabolism, and excretion, summarized as exposure parameters such as Cmax, AUC, clearance, and half-life that set dose and dosing interval.

• Pharmacovigilance (PV)

  Pharmacovigilance is the regulated safety discipline covering detection, assessment, understanding, and prevention of adverse drug reactions, and the reporting obligations that bind sponsors during trials and marketing authorisation holders for as long as a product stays on the market.

• Pharmacovigilance System Master File (PSMF)

  Pharmacovigilance System Master File (PSMF) is the detailed description of the pharmacovigilance system a marketing authorisation holder operates for EU-authorised medicines, kept at one registered EU site and produced to competent authorities within seven days of request.

• Phase 1 Clinical Trial (Phase 1)

  Phase 1 clinical trials are the first human studies of an investigational drug, designed to characterize metabolism, pharmacologic actions, and dose-related side effects rather than to prove effectiveness, typically enrolling 20 to 80 subjects.

• Phase 2 Clinical Trial (Phase 2)

  Phase 2 clinical trials are the controlled studies that evaluate whether a drug is effective in patients with the target disease and determine the dose, regimen, and endpoints that Phase 3 will confirm.

• Phase 3 Clinical Trial (Phase 3)

  Phase 3 clinical trials are expanded controlled studies run after preliminary evidence of effectiveness, sized at several hundred to several thousand subjects to establish the benefit-risk relationship and supply the substantial evidence supporting approval and physician labeling.

• PMA (Premarket Approval)

  PMA is the FDA's most stringent device marketing application, the pathway by which a Class III device wins approval on its own clinical and nonclinical evidence rather than by demonstrating equivalence to a marketed predicate.

• PMDA (Pharmaceuticals and Medical Devices Agency)

  PMDA is Japan's incorporated administrative agency that scientifically reviews drugs, medical devices, and cellular and tissue-based products for marketing approval, inspects the data and plants behind them, and runs post-marketing safety and relief services alongside MHLW.

• Post-Marketing Commitment (PMC)

  Post-marketing commitments are studies or clinical trials a sponsor agrees in writing to conduct after FDA approval, not compelled by statute or regulation the way post-marketing requirements are, yet still reported annually until FDA agrees they are fulfilled.

• Pre-Approval Inspection (PAI)

  Pre-Approval Inspection is an FDA facility inspection conducted while a drug marketing application is pending, testing whether the site can manufacture the product under cGMP and whether the application's data matches what the site actually did.

• Pre-Submission Meeting (Pre-Sub)

  Pre-Submission Meetings are formal, sponsor-requested meetings with FDA held before an application is filed, securing agency feedback on study design, evidence standards, and submission content while the plan can still change rather than after review begins.

• Primary Endpoint (Primary Endpoint)

  The primary endpoint is the pre-specified outcome measure a clinical trial is powered and statistically tested against, carrying the trial's efficacy claim; secondary and exploratory endpoints add supporting evidence but cannot substitute for it.

• Priority Review (Priority)

  Priority Review is an FDA marketing-application designation that shortens the agency's review-and-action target to six months, compressing the review clock only; it changes neither the evidence required nor the standard for approval.

• Process Analytical Technology (PAT)

  Process Analytical Technology is a system for designing, analyzing and controlling pharmaceutical manufacturing through measurements taken during processing rather than after it, so quality is assured by in-process control instead of end-product testing alone.

• Process Validation (PV)

  Process Validation is the documented, data-based demonstration that a manufacturing process consistently produces drug product meeting predetermined specifications, spanning process design through routine commercial production rather than a one-time qualification exercise.

• Protocol Amendment (Protocol Amendment)

  A protocol amendment is the IND submission that adds a new clinical protocol, changes an existing protocol, or adds an investigator; protocol changes must be submitted to FDA and approved by the IRB before implementation.

• Purple Book (Purple Book)

  The Purple Book is FDA's searchable list of biological products licensed under the Public Health Service Act, recording each product's licensure date, reference-product exclusivity, and biosimilarity or interchangeability status.