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Related Concept Videos

Drug Regulation01:25

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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...
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Clinical Trials: Overview01:11

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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...
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FDA Approved Drugs: Changes to Approved Drugs01:26

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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,...
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Preclinical Development: Overview01:28

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Preclinical development consists of a series of tests that ensure the safety and efficacy of a new therapeutic compound before it is tested in humans. There are four main phases to this process. First, safety pharmacology tests are conducted to ensure the drug does not produce any acutely harmful effects. These tests examine parameters such as bronchoconstriction, cardiac dysrhythmias, blood pressure changes, and ataxia. Next, preliminary toxicological testing is performed to determine the...
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Drug Administration and Therapy Phases: Overview01:26

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Drugs, the chemical agents used in diagnosing, treating, or preventing diseases, undergo a four-phase process of development: pharmaceutic, pharmacokinetics, pharmacodynamics, and therapeutic.
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Pharmacovigilance01:19

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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.
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Overview of FDA's Expanded Access Program for Investigational Drugs.

Jonathan P Jarow1, Peter Lurie2, Sarah Crowley Ikenberry1

  • 1Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD, USA.

Therapeutic Innovation & Regulatory Science
|May 30, 2017
PubMed
Summary
This summary is machine-generated.

Expanded access programs offer investigational drugs for serious diseases when no other options exist. Successful access requires collaboration between patients, the FDA, and healthcare providers.

Keywords:
expanded accessinvestigational new druginvestigational therapiessingle patient expanded access

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Area of Science:

  • Medical Science
  • Regulatory Affairs
  • Patient Advocacy

Background:

  • Expanded access, or compassionate use, provides investigational treatments for serious conditions lacking alternatives.
  • This pathway is crucial for patients unable to participate in clinical trials.

Purpose of the Study:

  • To outline the process and requirements for expanded access to investigational medical products.
  • To highlight the collaborative nature of successful expanded access.

Main Methods:

  • Review of US Food and Drug Administration (FDA) guidelines and regulations.
  • Analysis of the roles and responsibilities of key stakeholders in the expanded access process.

Main Results:

  • Expanded access requires FDA authorization and active participation from drug companies and healthcare providers.
  • The process facilitates patient access to novel therapies for unmet medical needs.

Conclusions:

  • Successful expanded access programs depend on multi-party cooperation.
  • This pathway represents a vital, albeit complex, option for patients with serious or life-threatening diseases.