What Happens After a Complete Response Letter (CRL) for a Generic ANDA? CDMO Support Options
Introduction When a Complete Response Letter (CRL) is issued for a Generic ANDA under 21 CFR 314.110, the applicant immediately […]
Case Study: Nitrosamine Compliance Strategy for a Biosimilar Seeking Simultaneous FDA and EMA Approval
Introduction: A Nitrosamine Compliance Strategy for Biosimilars is fast becoming a required part of modern pharmaceutical quality and regulatory planning,
Pharmacokinetics and Biodistribution of Peptide-Oligonucleotide Conjugate Therapeutics
Introduction Covalently attaching functional peptide vectors to synthetic nucleic acids can substantially modify the pharmacokinetics and biodistribution of oligonucleotide therapeutics
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Forced Degradation and Stress Testing Service for Biosimilar Drug Substances: ICH Q1A and ICH Q5C Compliance
Introduction: Forced Degradation Testing for Biosimilars is an important analytical strategy for understanding how a biosimilar drug substance changes when
505(b)(2) vs ANDA: Which Regulatory Pathway Should Your Generic Drug Use?
Introduction The choice between the 505(b)(2) vs ANDA Regulatory Pathway depends largely on whether the proposed drug product is an
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CMC Requirements for Dexamethasone Injection ANDA
Introduction: Dexamethasone Injection CMC requirements are a critical part of developing and submitting a generic injectable drug product through the
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Case Study: Silicone Lubricant Leachables in an Auto-Injector Primary Container
Introduction: Silicone Lubricant Leachables are chemical substances that can migrate from silicone-lubricated components of a pharmaceutical container or drug-delivery system
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Case Study: PLGA Long-Acting Injectable Formulation Development for a GLP-1 Receptor Agonist in Type 2 Diabetes
Introduction: The development of a PLGA Long-Acting Injectable Formulation for a GLP-1 receptor agonist can provide an important strategy for
Can You Switch CDMOs After an ANDA Has Been Submitted to the FDA?
Introduction Pharmaceutical sponsors can execute a Switch CDMO After ANDA Submission, but the regulatory approach depends on whether the ANDA
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Case Study: Analytical Method Development and Impurity Profiling for a Complex Cyclic Peptide API
Introduction Analytical Method Development and Impurity Profiling for complex cyclic peptide active pharmaceutical ingredients (APIs) establishes the analytical foundation necessary