Trusted Resource for Clinical Trials, Protocols & Progress
Fast Track is an official FDA program that expedites the development and review of drugs and biologics. It is designed for therapies that treat serious conditions and demonstrate the potential to address unmet medical needs. Sponsors may request Fast Track designation at any time during the drug development process, including before or after IND submission.
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The Committee for Medicinal Products for Human Use (CHMP) is the EMA’s key scientific body responsible for the evaluation of human medicines. It is composed of experts from EU member states, plus Iceland and Norway, with additional co-opted specialists when required. The CHMP ensures that decisions on human medicines, including clinical trials, are based on solid scientific evidence and consistent regulatory interpretation.
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CDSCO approval is mandatory for the following clinical trial types in India:
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Breakthrough Therapy Designation is a regulatory status granted to drugs or biologics intended to treat serious or life-threatening conditions and that demonstrate preliminary clinical evidence indicating substantial improvement over existing therapies on clinically significant endpoints. The designation is designed to expedite the development and review of such therapies through enhanced collaboration with the FDA.
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Scientific Advice is a voluntary, non-binding procedure through which the EMA provides guidance to sponsors on the best methods and practices for generating data during drug development. This guidance helps ensure that the resulting data meets EU regulatory expectations, reducing the risk of rejection or delays during the marketing authorization application (MAA) phase.
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An SAE is defined under Indian clinical trial regulations as any untoward medical occurrence that results in:
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The Real-Time Oncology Review (RTOR) program, launched by the FDA’s Oncology Center of Excellence (OCE) in 2018, allows the FDA to begin reviewing portions of a drug’s application (typically efficacy and safety data) before the entire New Drug Application (NDA) or Biologics License Application (BLA) is formally submitted. This rolling data submission model helps shorten the overall time to approval.
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Originally launched as a pilot in 2014, the Adaptive Pathways initiative (formerly known as adaptive licensing) is a regulatory pathway designed to enable early and progressive access to new medicines. It allows for initial approval in a restricted population based on early clinical data, with expansion to broader populations as additional evidence becomes available.
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Drug development is a complex and highly regulated process governed by national and international authorities. These regulatory bodies set the standards for clinical trial conduct, manufacturing practices, marketing authorizations, pharmacovigilance activities, and compliance. By adhering to these guidelines, sponsors ensure not only legal compliance but also ethical responsibility towards patients and public health.
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Bioavailability refers to the rate and extent to which an active drug ingredient is absorbed and becomes available at the site of action. Bioequivalence is demonstrated when two formulations of the same drug produce comparable bioavailability profiles under similar conditions.
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