Simplifying Global Compliance

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GMP Inspection Preparation Checklist: A Tool for Internal Auditing

This management report includes more than 650 items organized in three sections covering all aspects of quality manufacturing.

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Biological Risk Evaluation and Management for Medical Devices

Report shows how the FDA incorporates the two ISO standards in its medical device development policy, how the EU version of the two standards differs in significant ways and how the EU Medical Device Regulation may require further changes in the European standards.

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FDA Approves Two Drugs to Treat Bone Marrow Cancer

December 11, 2014

The drugs are from Amgen and Incyte. Read More

FDA Aims to Help Generics Obtain REMS-Protected Product Samples

December 11, 2014

The agency published draft guidance last week. Read More

Biomarkers for Drug-Induced Kidney Injury Get Boost From EMA, FDA

December 11, 2014

The European Medicines Agency is lending support to an initiative to qualify biomarkers that can provide early warning of an investigational compound’s risks of causing drug-induced kidney injuries. Read More

EU Ombudsman Wants Regulator To Explain Trial Data Redaction

December 11, 2014

The EU ombudsman is questioning the European Medicines Agency’s claim that it wasn’t violating any laws when it allowed AbbVie to redact information from clinical study reports. Read More

FDA Streamlines Critical Path Innovation Meetings Process

December 11, 2014

Researchers approaching the FDA with new drug development tools, such as potential biomarkers or innovative trial designs, now have a centralized place to bring their ideas for advice, thanks to a new streamlined system that replaces the old fragmented process. Read More

FDA Finalizes Guidance on Vaginal Microbicides for HIV Prevention

December 11, 2014

Clinical studies evaluating the safety and tolerability of vaginal microbicide gels to prevent HIV infections should use a scoring system to measure the presence and severity of rash, swelling, immune response and damage to local tissue, FDA final guidance says. Read More

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GMP Inspection Preparation Checklist: A Tool for Internal Auditing

Biological Risk Evaluation and Management for Medical Devices

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Regulatory Affairs
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FDA Approves Two Drugs to Treat Bone Marrow Cancer

FDA Aims to Help Generics Obtain REMS-Protected Product Samples

Biomarkers for Drug-Induced Kidney Injury Get Boost From EMA, FDA

EU Ombudsman Wants Regulator To Explain Trial Data Redaction

FDA Streamlines Critical Path Innovation Meetings Process

FDA Finalizes Guidance on Vaginal Microbicides for HIV Prevention

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European Biosimilars Makers Weigh in on Latest Draft Guidelines

FDA Mandates Pediatric Risk Information in Patient Counseling Labeling

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Japan Issues Rules for Combo Drugs Under Revised Regulations

HHS Protects Three Ebola Vaccine Manufacturers from Liability

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Regulatory Affairs
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