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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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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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Drug Control Governance: Regulatory Bodies and Their Impact01:03

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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...
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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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Product specifications define the acceptable quality of a pharmaceutical product by ensuring identity, purity, potency, and strength. These specifications serve as benchmarks during development, manufacturing, and post-approval quality control. Clinically relevant specifications are particularly important because they directly relate to a drug's safety and efficacy in clinical use.Dissolution studies are critical biopharmaceutic tools that link in vitro behavior to in vivo performance. They...
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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...
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FDA pharmaceutical quality oversight.

Lawrence X Yu1, Janet Woodcock1

  • 1Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Avenue, Silver Spring, MD 20993, USA.

International Journal of Pharmaceutics
|June 2, 2015
PubMed
Summary
This summary is machine-generated.

The U.S. Food and Drug Administration launched the Office of Pharmaceutical Quality (OPQ) to ensure high-quality medicines. This new office streamlines processes and enhances drug quality oversight for all medications.

Keywords:
Facility investigationsIntegrated quality assessmentPharmaceutical qualityPharmaceutical surveillanceQuality by designQuality manufacturing systems

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Area of Science:

  • Pharmaceutical Regulation
  • Drug Quality Assurance
  • Regulatory Science

Background:

  • The U.S. Food and Drug Administration (FDA) established the Center for Drug Evaluation and Research (CDER) Office of Pharmaceutical Quality (OPQ).
  • This initiative represents a significant advancement in ensuring the availability of high-quality medicines for the American public.
  • OPQ consolidates key functions to enhance regulatory effectiveness.

Purpose of the Study:

  • To introduce the strategic organization and objectives of the new Office of Pharmaceutical Quality (OPQ).
  • To highlight OPQ's role in advancing regulatory standards and drug quality surveillance.
  • To emphasize the integration of diverse expertise for a unified approach to pharmaceutical quality.

Main Methods:

  • Strategic reorganization of regulatory processes within CDER.
  • Implementation of innovative knowledge management and informatics for product quality.
  • Development of concerted strategies for parity in oversight of innovator and generic drugs, and domestic and international facilities.

Main Results:

  • Streamlined regulatory processes and advanced regulatory standards.
  • Aligned areas of expertise and originated surveillance of drug quality.
  • Promotion of emerging pharmaceutical technologies to enhance quality and manufacturing.

Conclusions:

  • The launch of OPQ signifies a unified approach to pharmaceutical quality, integrating review, inspection, surveillance, policy, and research.
  • OPQ aims to strengthen pharmaceutical quality on a global scale through a "One Quality Voice" motto.
  • This initiative is expected to enhance pharmaceutical quality and potentially revitalize the U.S. pharmaceutical manufacturing sector.