FDA Compliance
FEATURED REPORTS
WHAT'S NEW
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MasterControl facilitates accurate, efficient FDA compliance at Teva USA
by MasterControl Inc.
Case study
In this case study, MasterControl cut the time it took to modify approve documents that kept Teva Pharmaceuticals USA in total compliance with U.S. Food and Drug Administration (FDA) regulations.
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FDA compliance for the life sciences
by Microsoft Corp.
White paper
This white paper by Microsoft Corp. discusses the impact of FDA compliance on management strategy, production and information technology.
REPORTS BY SUBTOPIC
EU Clinical Trials Directive: Effects on clinical research
By Fulcrum Pharma Developments
White paper
Fulcrum Pharma Developments Inc. outlines the main objectives of the European Union (EU) Clinical Trials Directive and reviews how to respond so that clinical trials can be performed in the most cost-and time-effective manner.
Key tests for breakthrough blood safety system
By MDS Pharma Services
Case study
In this case study, MDS Pharma Services performs viral validations for Navigant Biotechnologies that help the company perfect the system, obtain Food and Drug Administration approval and move the product to market.
Are you ready for an FDA inspection?
By MasterControl Inc.
White paper
This white paper by MasterControl Inc. describes how it went about becoming compliant with Food and Drug Administration standards, the difficulties involved and how companies can go through the same process.
Phase I-IIA Clinical Pharmacology Services
By AAI Pharma Inc.
Product collateral
AAIPharma's Phase I-IIA Clinical Pharmacology services offer experienced research teams of physicians, nurses, technicians and CRAs, rapid subject recruitment, healthy volunteers as well as special populations, a focus on volunteer and patient safety, regulatory compliance, and strict adherence to the protocol.
PAT and data availability
By Aegis Analytical Corp.
Application note
In this application note, Aegis Analytical Corp. describes how process analytical technology (PAT) addresses data availability issues in process manufacturing and outlines how PAT helps the U.S. Food and Drug Administration (FDA) achieve significant improvements in pharma compliance and performance.
FDA Guidance for Industry: Gene Therapy Clinical Trials
White paper
This guidance provides sponsors of gene therapy studies, recommendations regarding the design of studies to include the collection of data on delayed adverse events in subjects who have been exposed to investigational gene therapy products.
FDA, HIPAA and clinical research
By Compliance Gurus Inc.
White paper
This white paper by Compliance Gurus Inc. identifies the similarities between HIPAA regulations and the FDA's Code of Federal Regulations and explain why the healthcare, drug and medical device industries must be mindful of both sets of federal regulations when conducting clinical research.
The era of clinical trial registries
By Campbell Alliance
White paper
This white paper by Campbell Alliance describes clinical trial registries, explains the basic principles and minimum requirements for registries, and discusses their potential benefits.
