Regulations and Guidelines
Showing 33–48 of 133 results
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EMA Classification and Analysis of the GCP Inspection Findings 2000-2012
In December, 2014, the EMA (European Medicines Agency) published this analysis for the 398 EMA GCP (Good Clinical Practice) inspections conducted in the years 2000-2012.
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FDA Guidance: Changes to an Approved Application: Biological Products: Human Blood and Blood Components, 12/14
This December 2014 US FDA guidance provides manufacturers of licensed blood and blood components with recommendations on submission of BLA changes.
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FDA Guidance: Design Considerations for Devices Intended for Home Use, 11/14
November 2014 FDA guidance on designing and developing home use devices that comply with safety standards, effectiveness standards, and regulatory requirements.
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FDA Guidance: Contents of Premarket Submissions for Management of Cybersecurity in Medical Devices, 10/14
In October, 2014 the FDA published this guidance to the cybersecurity issues that manufacturers should consider in the design and development of their medical devices.
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OECD The Application of GLP Principles to Computerised Systems DRAFT, 9/14
2014 draft OECD publication of standards for laboratory computer systems used in clinical studies destined for regulatory submissions.
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FDA Guidance: FDA Decisions for Investigational Device Exemption Clinical Investigations, 8/14
2014 FDA recommendations to industry, investigators, IRBs, and FDA staff to promote the initiation of clinical investigations to evaluate new medical devices
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PIC/S PE 011-1 Guide to Good Distribution Practice for Medicinal Products, 6/14
In June, 2014, this PIC/S Guide went into effect to ensure high standards of quality assurance and integrity for distribution of medicinal product.
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MHRA Guidance: Medical Device Stand-Alone Software (Including Apps), 3/14
March 2014 MHRA guidance on medical device stand-alone software, including apps, for people working in healthcare and companies developing devices.
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PIC/S PE 010-4 Guide to Good Practices for the Preparation of Medicinal Products in Healthcare Establishments, 03/14
March, 2014 PIC/S guide for inspectors to use during audits of healthcare establishments that prepare medicinal products for direct supply to patients.
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WHO Annex 2 Good Manufacturing Practices for Pharmaceutical Products, 1/14
2014 WHO Committee on Specifications for Pharmaceutical Preparations update to Annex 2, Good Manufacturing Practices for Pharmaceutical Products: Main Principles.
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EMA Reflection Paper on Risk Based Quality Management in Clinical Trials, 11/13
This 2013 EMA Reflection Paper supports GCP principles by recommending a systematic, risk-based approach to quality management of clinical trials.
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EC Guidelines on Good Distribution Practice of Medicinal Products for Human Use 2013 v2, 11/13
In November, 2013 the EU Commission published Guidelines on Good Distribution Practice of Medicinal Products for Human Use. This replaces the March ’13 GDP directive.
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FDA Guidance: Investigational Device Exemptions for Early Feasibility Medical Device Studies, 10/13
2013 FDA guidance to industry, clinicians, and innovators, regarding Investigational Device Exemptions (IDE) applications for early feasibility studies of high risk devices
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FDA Guidance: Electronic Source Data in Clinical Investigations, 9/13
In September, 2013, the FDA issued this guidance to recommend practices to help ensure the reliability, quality, integrity, and traceability of electronic source data.
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FDA Draft Guidance: Manufacturing Arrangements for Drugs – Quality Agreements, 5/13
This May 2013 FDA draft guidance make recommendations on the contents of contract manufacturing Quality Agreements and delineation of responsibilities for companies.
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FDA Guidance: Blood Establishment Computer System Validation in the User’s Facility, 4/13
In April, 2013, the FDA published this guidance to assist blood establishments in developing computer system validation programs consistent with recognized principles.
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