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Related Concept Videos

Clinical Trials: Overview01:11

Clinical Trials: Overview

Clinical development focuses on how the drug will interact with the human body and encompasses four key phases of clinical trials, each serving a specific purpose in assessing the safety and effectiveness of new drugs. These phases overlap and build upon one another. Phase I involves a small group of healthy volunteers (typically 20-80 individuals) or, in cases where significant toxicity is expected, patients with the targeted disease, such as cancer or AIDS. The volunteers are tested for...
Drug Regulation01:25

Drug Regulation

Drug regulation encompasses the management of drug usage by evaluating its safety and efficacy through assessments conducted by regulatory authorities. Regrettably, the history of drug regulation is marred by several catastrophic events. One such incident is the Elixir Sulfanilamide tragedy, in which the toxic compound diethyl glycol was included in a sweet-tasting medication, leading to numerous fatalities. This event prompted the enactment of the Food, Drug, and Cosmetic Act in 1938. Under...
Pharmacovigilance01:19

Pharmacovigilance

Post-marketing surveillance is a critical component of pharmaceutical regulation, often uncovering unanticipated adverse drug reactions (ADRs) once a drug is widely used over an extended period.
This process, termed pharmacovigilance, aims to detect, evaluate, and minimize harmful effects related to medication use. The data collection for pharmacovigilance depends on spontaneous reporting systems, where healthcare professionals or patients voluntarily report suspected ADRs.
In some cases, there...
Drug Products: Biologics, Biosimilars and Interchangeables01:28

Drug Products: Biologics, Biosimilars and Interchangeables

Biologics, derived from living sources such as humans, animals, or microorganisms, represent a significant category of pharmaceuticals. These complex molecules, developed through advanced biotechnological methods or purified from natural sources, include essential medical treatments like insulin and growth hormones. The complexity of biologics arises from their large molecular structures and the intricate processes required for their production, making them distinct from conventional...
FDA Approved Drugs: Changes to Approved Drugs01:26

FDA Approved Drugs: Changes to Approved Drugs

Post-approval, manufacturers may modify an approved new or generic drug product. Such modifications can encompass alterations in the Active Pharmaceutical Ingredient (API), manufacturing process, formulation, batch size, manufacturing site, and container closure system (FDA Guidance for Industry, April 2004). Often, a drug product may undergo multiple changes.These modifications require careful evaluation to determine their potential impact on the drug product's identity, strength, quality,...
Impact of Pharmacokinetic–Pharmacodynamic Models: Regulatory Decisions01:15

Impact of Pharmacokinetic–Pharmacodynamic Models: Regulatory Decisions

PK–PD modeling has significantly influenced FDA regulatory decisions, particularly drug approval, dosage optimization, and labeling. These models integrate pharmacokinetics (PK) and pharmacodynamics (PD) to predict drug behavior and effects, aiding in optimizing dosing regimens and enhancing the probability of clinical trial success.One notable example is Nesiritide (Natrecor®), a recombinant human brain natriuretic peptide for treating acute decompensated congestive heart failure (CHF).

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Related Experiment Video

Updated: Jul 13, 2026

In Vivo Alkaline Comet Assay and Enzyme-modified Alkaline Comet Assay for Measuring DNA Strand Breaks and Oxidative DNA Damage in Rat Liver
10:38

In Vivo Alkaline Comet Assay and Enzyme-modified Alkaline Comet Assay for Measuring DNA Strand Breaks and Oxidative DNA Damage in Rat Liver

Published on: May 4, 2016

16.1K

FDA Reported Use of Patient Experience Data in 2018 Drug Approvals.

Cameron M Kieffer1, Alexis Reisin Miller1, Benjamin Chacko1

  • 1Global Regulatory Science and Policy, NA, Sanofi, Bethesda, Maryland, USA.

Therapeutic Innovation & Regulatory Science
|October 11, 2019
PubMed
Summary

Patient experience data (PED) was used in 70.8% of new molecular entity approvals in 2018. Patient-reported outcomes were the primary source of PED, highlighting its growing role in drug reviews.

Keywords:
21st Century Cures ActDrug ApplicationsPatient Focused Drug DevelopmentPatient Reported OutcomesRegulatory Science

Related Experiment Videos

Last Updated: Jul 13, 2026

In Vivo Alkaline Comet Assay and Enzyme-modified Alkaline Comet Assay for Measuring DNA Strand Breaks and Oxidative DNA Damage in Rat Liver
10:38

In Vivo Alkaline Comet Assay and Enzyme-modified Alkaline Comet Assay for Measuring DNA Strand Breaks and Oxidative DNA Damage in Rat Liver

Published on: May 4, 2016

16.1K

Area of Science:

  • Pharmacovigilance and Drug Safety
  • Regulatory Science
  • Patient-Centered Research

Background:

  • Patient experience data (PED) systematically collects patient perspectives and priorities.
  • PED can enhance traditional clinical trial data for regulatory reviews.
  • The 21st Century Cures Act mandates FDA statements on PED consideration in drug approvals.

Purpose of the Study:

  • To assess the FDA's consideration of PED in drug application approvals.
  • To establish a baseline for FDA's use of PED under the Cures Act.
  • To inform future drug development by ensuring patient voices are heard.

Main Methods:

  • Analyzed FDA Review Documentation for 59 new molecular entities (NMEs) approved in 2018.
  • Indexed and cross-referenced PED information against FDA review and regulatory data.
  • Quantitatively described and visualized reported PED usage.

Main Results:

  • Of 59 NME approvals, 48 included tables on PED usage.
  • 70.8% of these approvals (34/48) reported the use of PED.
  • Patient-reported outcomes (PROs) were the most common PED source, used in 60.4% of reviews.

Conclusions:

  • This study provides an initial assessment of FDA's consideration of PED in regulatory decision-making.
  • Establishes a baseline for FDA's utilization of PED.
  • Findings can guide efforts to ensure patient experiences are integral to future drug development.