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Tanksley Consulting Group Pharmaceutical Quality Regulatory Compliance Consulting. Sarah Tanksley
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RESOURCES
Quick Links
- U.S. Food and Drug Administration HOME
- U.S. Food and Drug Administration – Guidance, Compliance & Regulatory Information
- FDA Warning Letters
- U.S. Pharmacopeia and The National Formulary
- Parenteral Drug Association
- International Conference on Harmonization Documents
- International Society for Pharmaceutical Engineering
- European Medicines Agency
- Australian Therapeutic Goods Administration
- Canada Health Products and Food Branch
Regulatory Affairs
- Medical Device Reporting for Manufacturers: This guidance document describes and explains the Food and Drug Administration’s (FDA, we, us) current regulation that addresses reporting and recordkeeping requirements applicable to manufacturers of medical devices for device-related adverse events and certain malfunctions.
- CDER Drug Safety Priorities: This report goes beyond previously issued safety-related reports to offer a broader picture of FDA’s safety efforts, highlighting the critical advantages gained through a range of multidisciplinary collaborations and partnerships.
- FDA Briefing Document: Pharmacy Compounding Advisory Committee (PCAC) Meeting
The attached package contains background information prepared by the Food and Drug Administration (FDA) for the panel members of the Pharmacy Compounding Advisory Committee (advisory committee).
- Advanced Manufacturing: A Snapshot of Priority Technology Areas Across the Federal Government. Product of the Subcommittee for Advanced Manufacturing of the National Science and Technology Council
- Advanced Therapy Medicines: Exploring Solutions to Foster Development and Expand Patient Access in Europe. Outcome of a multi-stakeholder meeting with experts and regulators held at EMA on Friday 27 May 2016
- Data Integrity and Compliance With CGMP Guidance for Industry. DRAFT GUIDANCE. U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) Center for Biologics Evaluation and Research (CBER) Center for Veterinary Medicine (CVM) April 2016 Pharmaceutical Quality/Manufacturing Standards (CGMP)