Regulatory Updates- Jan 2019

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Labeling for Human Prescription Drug and Biological Products Approved Under the Accelerated Approval Regulatory Pathway Guidance for Industry

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India Prohibits 80 FDCs After Prolonged Legal Dispute

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TGA Brings 6 Guidance Documents in Line With PIC/S Guide to GMP

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FDA: Immunogenicity Testing of Therapeutic Protein Products — Developing and Validating Assays for Anti-Drug Antibody Detection

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FDA – REMS Assessment: Planning and Reporting Guidance for Industry

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Overview of comments received on ICH guideline Q12 on technical and regulatory considerations for pharmaceutical product lifecycle management (EMA/CHMP/ICH/804273/2017)

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How to make regulatory medicines submissions to the MHRA if the UK leaves the EU with no deal

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 UK Details Plans to Tackle Antimicrobial Resistance Over the Next 20 Years

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European Commission Updates Q&A on Safety Features for Medicinal Products

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MHRA-Good pharmacovigilance practice (GPvP)

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EMA starts moving to Amsterdam

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Health Canada – Draft Guidance Document – Software as a Medical Device (SaMD)

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FDA Pushes Back eCTD Deadline for Type III DMFs Again

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Electronic product information for human medicines in the EU – draft key principles

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 Marketing Status Notifications: FDA Drafts Guidance

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S11 Nonclinical Safety Testing in Support of Development of Paediatric Medicines

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Please note, the provided links and the information is publicly available.