GMP: FDA: Ensuring the Safety of Vaccines in the United States

On 2 April, the FDA posted the current updates on \"Ensuring the Safety of vaccines in the United States\" and on \"Understanding the Vaccine Adverse Event Reporting System (VAERS)\". ...

FDA: Media Fills for Validation of Aseptic Preparations for Positron Emission Tomography

This guidance represents the Food and Drug Administration\'s (FDA\'s) current thinking on this topic. It is intended to help manufacturers of positron emission tomography (PET) drugs meet the ...

GMP: FDA publishes Draft Guidance on Clinical Studies for Medical Devices

At the end of 2011 the FDA published 2 draft guidance documents on clinical studies for medical devices. In addition to that, the FDA announced a pilot programme for the latter draft guidance. ...

GMP: The new role of the Responsible Person for Good Distribution Practices

The European Commission is currently revising the \'Guideline on Good Distribution Practice of Medicinal Products for Human Use\". The current Guideline was first published in 1994. The new ...

GMP: Significant Changes in HPLC System Suitability: New USP Provisions Planned

A revision of General Chapter on Chromatography is proposed in the Pharmacopeial Forum (volume 38, edition 2). This new chapter has a major impact on system suitability tests (SST). ...

EMA: Reflection paper for laboratories that perform the analysis or evaluation of clinical trial samples

The purpose of this reflection paper is to provide laboratories that perform the analysis or evaluation of human samples collected as part of a clinical trial, with information that will help them ...

EMA: Guideline on the processing of renewals in the centralised procedure

This guideline considers issues associated with the processing of renewals in the centralised procedure, with an aim of giving procedural guidance to marketing authorisation holders (MAHs). It has ...

GMP: GMP Requirements for Pharmaceutical Excipients: NSF International publishes new Draft Standard

The NSF International is one of the U.S. American organisations which create standards for medical and cosmetic consumer goods and it has recently published a draft entitled \"Good Manufacturing ...

EMA: Reflection paper on the pharmaceutical development of intravenous medicinal products containing active substances solubilised in micellar systems

This paper describes a basic package of information which could be relevant to confirm the sound pharmaceutical development and full characterisation of products of this type. ...

EMA: Reflection paper on risk mitigation measures related to the environmental risk assessment of veterinary medicinal products

This reflection paper provides a critical review of the adequacy/appropriateness of risk mitigation measures included in current marketing authorisations of veterinary medicinal products. ...

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