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RAPS: FDA Withdraws Document Calling on Biosimilar Developers to Submit 10 Random Suffixes

30.06.2016
The US Food and Drug Administration (FDA) on Tuesday withdrew a document submitted to the Office of Management and Budget (OMB) that offered new details on how biosimilar developers would submit ...

FDA: Early Clinical Trials with Live Biotherapeutic Products: Chemistry, Manufacturing, and Control Information

30.06.2016
This guidance focuses on the chemistry, manufacturing, and control (CMC) information that you should submit in an IND for an LBP. This guidance is applicable to all INDs of LBPs, whether clinical ...

FDA: Elemental Impurities in Drug Products Guidance for Industry

30.06.2016
This draft guidance provides recommendations regarding the control of elemental impurities of human drug products marketed in the United States consistent with implementation of International ...

EMA: Guideline on user safety of topically administered veterinary medicinal products

30.06.2016
Applications for marketing authorisations for veterinary medicinal products (VMPs) in the European Union are issued in accordance with Directive 2001/82/EC as amended by Directive 2004/28/EC and ...

EMA: Improving safety of first-in-human clinical trials

09.06.2016
EMA starts EU-wide reflection on necessary changes to best practices. The European Medicines Agency (EMA) has started a review of the guidelines that describe first-in-human clinical trials and ...

EMA: Regulation of advanced therapy medicines

09.06.2016
Report details concrete proposals to encourage development and authorisation of advanced therapy medicinal products (ATMPs) in the EU. The European Medicines Agency (EMA) today published a report ...

EMA: Draft guideline on core SmPC and package leaflet for gadoteric acid

09.06.2016
This guideline describes the information to be included in the summary of products characteristics (SmPC) and package leaflet for gadoteric acid. ...

EMA: Draft guideline on the plant testing strategy for veterinary medicinal products

09.06.2016
Plant toxicity tests are used in the terrestrial environmental risk assessment of veterinary medicinal products (VMPs) as described in the VICH guideline on environmental impact assessment for ...

FDA: Considerations for Use of Histopathology and Its Associated Methodologies to Support Biomarker Qualification

09.06.2016
This guidance is intended to assist submitters of a biomarker for qualification that conduct nonclinical studies for which histopathology is used as a reference or truth standard (Zhou et al. ...

FDA: Use of Electronic Health Record Data in Clinical Investigations

09.06.2016
This guidance is intended to assist sponsors, clinical investigators, contract research organizations, institutional review boards (IRBs), and other interested parties on the use of electronic ...