Tag: Guidance

NICE Published Draft Guidance Recommending Neratinib for People with Early Breast Cancer

cancer treatment
NICE has published draft guidance recommending neratinib as an additional treatment for some people with early hormone-receptor-positive, human epidermal growth factor receptor 2 (HER2)-posi...

FDA Released Updated Guidance on Devices in the Magnetic Resonance Environment

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The draft guidance issued offers updated testing and labeling advice to assess the safety and compatibility of medical devices for the magnetic resonance (MR) environment. Once finalized, the 26-pa...

FDA Issued Three Guidance Documents Targetting Women’s Health and Neonatal Care

fda office
The US Food and Drug Administration (FDA) issued three final guidance documents to aid the development of new drugs for uncomplicated urinary tract infections (uUTI), bacterial vaginosis (BV) and vulv...

NICE Review on its Drug Development Guidances

Following approval at its recent Board meeting NICE has confirmed the details of its review of the methods it uses to develop guidance on drugs, medical devices and diagnostics. The purpose of the ...

Global Guidance on Medicines and Diagnostic Tests Updated by WHO

WHO’s Essential Medicines List and List of Essential Diagnostics are core guidance documents that help countries prioritize critical health products that should be widely available and affordable thro...

Medical Device Coordination Group Published Guidance Documents on MDR and IVDR

medical-devices
On 1 July 2019, the Medical Device Coordination Group (MDCG) published two guidance documents on the Medical Device Regulation (MDR) and the In-Vitro Diagnostics Regulation (IVDR). The fo...

FDA’s Statements on Steps to Make Labeling Information Consistent and Clear

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The FDA is committed to making sure that health care professionals and patients have up-to-date, accurate and actionable information about prescription medications so that informed treatment decisions...

EU Published Guidance to Help Verify Compliance with the Regulation

Back in 2011, the European Commission (EC) published Directive 2011/62/EC, the so-called Falsified Medicines Directive (FMD). The main goal was to support the fight against counterfeit medicines. T...

FDA Statement On Policies to Understand Effects of Drugs in Pregnant and Nursing Women

It can be a challenge for health care professionals and patients to find quality scientific information about the safety of drugs and biological products when used during pregnancy or breastfeeding. E...

Updated Obligations for Drug Shortage in Australia

The Australian medicines regulator has updated its guidance on reporting obligations for pharmaceutical companies, mandating confidential reporting of all shortages. The document, published by the ...

Ph. Eur. Approved New Guide on Monographs on Vaccines and Immunosera

At its 162nd session, the European Pharmacopoeia Commission (Ph. Eur.) approved a new edition of the Guide to the Preparation and Use of Monographs on Vaccines and Immunosera for Human Use. The docume...

FDA Guidance to Support Development of Rare Diseases Treatments

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The US Food and Drug Administration (FDA) published new draft guidance to help inform the design and implementation of natural history studies that can be used to support the development of treatments...

FDA’s Guide on Immunogenicity Testing of Therapeutic Protein Products

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For the evaluation of pharmacokinetics, pharmacodynamics, efficacy and safety of biological drugs and active substances, possible immunareactions of patients are of decisive importance. Especially in ...

FDA Final Guidance – Warning of Recalls

The U.S. Food and Drug Administration (FDA) recently released the final guidance entitled “Public Warning and Notification of Recalls.” The announcement of the guidance has been published in the Feder...

REMS Assesment Guidance from FDA

On January 24, 2019, FDA published guidance on the planning and reporting of the assessment of risk evaluation and mitigation strategies (REMS) for drugs and biologics. The development of a REMS Asses...

FDA Guidance to Clarify the Role of Data Integrity in cGMP

The topic data integrity is still in the focus of international authorities. Although integrity of data has been observed since the beginning of GMP, monitoring authorities started addressing the topi...