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    Journey of a Drug From Concept to Approval

    This article reviews the process of getting a new drug to market from the laboratory to the pharmacy. It addresses discovery and the developmental stages along the way, including finding lead compounds (drug discovery), target validation (drug development), and testing through pre-clinical trials, clinical trials, and post-production studies for acquiring marketing and long-term safety data. Introduction A molecule's journey from laboratory concept to a consistent and w...
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    Preparing for and Managing FDA Inspections

    The article discusses best practices for a manufacturer to stay 'inspection ready' on a day-to-day basis with a focus on how to prepare for and successfully manage FDA inspections from start to finish. Introduction For pharmaceutical manufacturers, US Food and Drug Administration (FDA) inspections are an occasional part of being in business and perhaps a fact-of-life. While FDA is required to inspect drug manufacturing facilities every two years, the agency is also au...
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    Bioequivalence Studies of Solid Oral Dosage Forms Overview

    The article discusses regulations and guidance for conducting bioavailability and bioequivalence studies required to obtain generic product approval across various markets. Included are comparative regulatory approaches for establishing bioequivalence of generic drugs to their corresponding reference drugs across various international jurisdictions, including Australia, Canada, EU, Japan and the US. Introduction 'Generic' drugs offer a significant cost saving and are ...
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    FDA Inspections and Outcomes for Oral Solid Dosage (OSD) Manufacturing Facilities

    The article discusses various types of current Good Manufacturing Practice (CGMP) inspections conducted by the US Food and Drug Administration (FDA) at oral solid dosage forms manufacturing facilities. It also elaborates on types of inspections, approaches to investigations, limitations of these inspections and major inspection outcomes in the event of deficiencies, including 483s, Warning Letters and Establishment Investigation Reports (EIRs). Introduction Civil and ...
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    Conditional Approvals for Early Access to New Medications

    This article provides insight into Conditional Approvals (CAs) and Conditional Marketing Approvals (CMAs) as developed across several jurisdictions to potentially provide earlier access to new medicines. The author explains the specifics regarding regulatory requirements for obtaining CAs in the European Union (EU), Japan and the US. Introduction Before a medicinal product for human use is authorized to enter the market, it must undergo extensive study to ensure its s...