Standardization of Data and Documentation Practices for Product Tracing Guidance for Industry
On February 28, 2018, FDA issued draft guidance on Standardization of Data and Documentation Practices for Product Tracing. This draft guidance aims [...]
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GMP Guide for Drug Products GUI-001 Canada
This document offers guidelines for interpretation of Good Manufacturing Practices (GMP) as applied in Canada in order to comply with [...]
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Definitions of Suspect Product & Illegitimate Product for Verification Obligations Under the Drug Supply Chain…
The Drug Supply Chain Security Act ( DSCSA ) amended the Federal Food, Drug, and Cosmetic Act ( FD&C Act [...]
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FDA Unique Device Identification: Direct Marking of Devices
Unique Device Identification: Direct Marking of Devices is a guidance document issued by the FDA on 17 November 2017 to [...]
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FDA Grandfathering Policy for Packages and Homogenous Cases of Product Without a Product Identifier
On November 27, 2017, FDA issued a draft guidance to help trading partners (manufacturers, repackagers, wholesale distributors, and dispensers) understand their compliance [...]
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CDER Issues Planned Guidance Agenda for CY2018
On January 19, 2018, CDER issued their updated CY2018 Guidance Agenda, which outlines new and revised draft guidances CDER plans [...]
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EMA Guideline on Manufacture of the Finished Dosage Form
The purpose of this guidance is to provide clarification on the type and level of information to be included in [...]
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Classification of Products as Drugs and Devices & Additional Product Classification Issues: Guidance for Industry…
FDA is providing final guidance on issues frequently raised in relation to Requests for Designation (RFDs) and other classification activities. [...]
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Product Identifier Requirements Under the Drug Supply Chain Security Act – Compliance Policy.
The Drug Supply Chain Security Act (DSCSA) was signed into law on November 27, 2013. Section 202 of the DSCSA [...]
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FDA Drug Supply Chain Security Act Implementation: Identification of Suspect Product and Notification
On December 9, 2016, FDA issued guidance for industry entitled ‘‘Drug Supply Chain Security Act Implementation: Identification of Suspect Product [...]
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EMA Implementation Strategy of ICH Q3D Guideline
On 08 March 2017, EMA issued an implementation strategy of the ICH Q3D guideline that addresses specific considerations to enable [...]
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EU ICH Guideline Q3C R6 on Impurities Guideline for Residual Solvents
On 6 December 2016 the European Medicines Agency issued a revision to the “ICH guideline Q3C (R6) on Impurities: Guideline [...]
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Guidance for Industry and FDA Staff: Current Good Manufacturing Practice Requirements for Combination Products
This guidance describes and explains the final rule on current good manufacturing practice (CGMP) requirements for combination products that FDA [...]
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Agreement on Mutual Recognition Between EU Community and US FDA
The US FDA and the EU announced that they have completed an exchange of letters to amend the Pharmaceutical Annex [...]
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