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Investigational New Drugs: Types and Application Procedures
Investigational New Drugs (INDs) are at the forefront of pharmaceutical innovation and new drug development. This article outlines the importance of INDs, types of IND applications, procedures, and their implications on the pharmaceutical landscape.
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The Investigational New Drug (IND) program is an initiative administrated by the United States Food and Drug Administration (FDA) whereby a pharmaceutical company is granted permission to begin human clinical trials on an experimental drug. A similar procedure is followed by the European Medicines Agency (EMA) in the European Union, where the IND is referred to as an Investigational Medicinal Product (IMP).
Types of investigational new drugs under the FDA program include:
Emergency Use INDs: Also known as “compassionate use” or “single-patient INDs”, this application is filed for emergency use of an unapproved drug when circumstances do not allow for sufficient time to submit an IND in accordance with current regulations. An emergency use IND is usually used for conditions deemed “life-threatening” when no standard treatments are available.
The five components of an IND application include:
The IND application must also include an Investigator’s Brochure disclosing the following information:
Upon submission, the FDA has 30 days to object to the IND, otherwise it automatically takes effect and clinical trials typically commence. Information for the procedures under EMA regulations is available here.
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Different countries and jurisdictions may have varying regulatory requirements, with poor enforcement of relevant rules and regulations. There may be accountability and transparency issues associated with manufacturing and distribution, which increases your risk of receiving non compliant products.
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Several outcomes can occur if the FDA objects to an IND application, including:
Staying informed about INDs is crucial to the long-term viability of your research practice, education program, or pharmaceutical business. MedicaPharma, an EU-based pharmaceutical distribution partner, can assist you with expertise and offer access to GMP-certified APIs and pharmaceutical intermediates for research or commercial endeavours.
Contact us to learn more about investigational new drugs and their impact on your business.
Investigational New Drugs (INDs) significantly impact the pharmaceutical industry by driving innovation, refining development strategies, and strengthening the regulatory process.
Investigational New Drugs (INDs) and New Chemical Entities (NCEs) are related pharmaceutical industry concepts, however they differ in terms of drug development. NCEs contain unapproved active pharmaceutical ingredients (APIs) while INDs are developed drugs undergoing approval before clinical trials.
Yes, investigational new drugs (INDs) can be accessed by patients through safety trials conducted by pharmaceutical companies. Following approval by the US Food and Drug Administration (FDA) or the EU European Medicines Agency (EMA), INDs are available via the clinical trial process.
The five components of an Investigational New Drug (IND) application include: (1) preclinical testing to assess the compound’s safety, (2) disclosure of manufacturing information, (3) investigator information that discloses the investigator’s qualifications, (4) clinical trial protocols, and (5) commitments that include informed consent, institutional review board (IRB) evaluation, and compliance with investigational new drug regulations.
Contact MedicaPharma to learn more about investigational new drugs, their impact on your business, and how they move through the regulatory approval process.
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Obtaining your desired quotation from MedicaPharma is easy; simply complete the form below to begin processing your quote request.
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Obtaining your desired quotation from MedicaPharma is easy; simply complete the form below to begin processing your quote request.
Please note: MedicaPharma cannot and will not supply customers in the United States due to regulatory restrictions.
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