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Related Concept Videos

Drug Control Governance: Regulatory Bodies and Their Impact01:03

Drug Control Governance: Regulatory Bodies and Their Impact

Drug control governance involves the oversight and regulation of pharmaceuticals to ensure their safety and efficacy while preventing illegal drug use and trafficking. Regulatory bodies, including the US Food and Drug Administration (FDA) and the European Union's European Medicines Agency (EMA), play a central role in this process. These agencies evaluate the safety and efficacy of drugs before they can be marketed. They fund clinical trials and assess the benefits and risks associated with a...
Global Regulatory Systems01:28

Global Regulatory Systems

Global regulatory systems in bacteria enable rapid and coordinated responses to environmental changes by integrating sensory inputs with gene expression, ensuring efficient adaptation to fluctuating conditions. Key global regulatory mechanisms include regulons, two-component systems, sigma factors, and secondary messengers.Regulons and Global RegulatorsA regulon is a collection of genes and operons controlled by a common global regulator. These regulators enable bacteria to prioritize resource...
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).
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...
Translational Regulation01:29

Translational Regulation

Translational regulation in prokaryotes ensures efficient protein synthesis by controlling ribosome access to mRNA. This regulation is mediated by secondary RNA structures, including translational riboswitches, RNA thermometers, and small RNAs (sRNAs), which respond to intracellular and environmental signals to modulate gene expression.Translational RiboswitchesRiboswitches in the leader region of mRNAs can regulate translation by altering the accessibility of the Shine-Dalgarno (SD) sequence,...
Positive Regulator Molecules02:39

Positive Regulator Molecules

Mitotic cell division results in daughter cells that exactly resemble the parent cell. However, errors in the DNA replication or distribution of genetic material may lead to genetic mutations that may be passed down to every new cell formed from the resulting abnormal cell. Propagation of such mutant cells is restricted through checkpoint mechanisms present at different stages of the cell cycle. These checkpoints involve regulator molecules that either promote or demote cell cycle events.

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Regulatory T cells: Therapeutic Potential for Treating Transplant Rejection and Type I Diabetes
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Regulatory T cells: Therapeutic Potential for Treating Transplant Rejection and Type I Diabetes

Published on: August 20, 2007

Transforming regulatory science 2012: making a difference.

J L Goodman1

  • 1Office of the Chief Scientist/Office of the Commissioner, US Food and Drug Administration, Department of Health and Human Services, Silver Spring, Maryland, USA. jesse.goodman@fda.hhs.gov

Clinical Pharmacology and Therapeutics
|February 21, 2012
PubMed
Summary
This summary is machine-generated.

Regulatory science innovations can accelerate medical product development, overcoming current delays and costs. The US Food and Drug Administration

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Last Updated: May 24, 2026

Regulatory T cells: Therapeutic Potential for Treating Transplant Rejection and Type I Diabetes
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Published on: August 20, 2007

Using SCOPE to Identify Potential Regulatory Motifs in Coregulated Genes
07:55

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Published on: May 31, 2011

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Area of Science:

  • Regulatory science
  • Medical innovation
  • Public health transformation

Background:

  • Scientific revolutions offer potential to revolutionize medicine and public health.
  • Current product development and evaluation processes are slow and expensive.
  • There is a need for enhanced regulatory science to facilitate translation of scientific advancements.

Purpose of the Study:

  • To outline opportunities for regulatory science to transform product development.
  • To present the US Food and Drug Administration's plan for advancing regulatory science.
  • To highlight the importance of scientific excellence and collaboration in driving change.

Main Methods:

  • Review of the US Food and Drug Administration's "Advancing Regulatory Science" plan.
  • Identification of eight key priorities and associated actions.
  • Emphasis on public and private sector collaboration.

Main Results:

  • The FDA's plan identifies critical areas for regulatory science advancement.
  • Numerous actions are proposed to catalyze transformation in product development.
  • Scientific excellence and collaboration are identified as essential drivers.

Conclusions:

  • Advancing regulatory science is crucial for accelerating the translation of scientific breakthroughs into medical products.
  • Collaboration between public and private sectors is vital for successful implementation.
  • These changes are expected to benefit global health and economies.