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FDA: Investigational New Drug Applications for Positron Emission Tomography (PET) Drugs

13.12.2012
This guidance summarizes the investigational new drug application (IND) process for unapproved positron emission tomography (PET) drugs, makes recommendations on how to submit an IND, provides ...

EMA: Draft guideline on the clinical investigation of human normal immunoglobulin for subcutaneous and / or intramuscular administration (SCIg / IMIg)

06.12.2012
This guideline describes the information to be documented when an application is made for a marketing authorisation for a human normal immunoglobulin for subcutaneous or intramuscular use (SCIg / ...

EMA: Draft guideline on the clinical investigation of hepatitis-B immunoglobulins

06.12.2012
This guideline describes the information to be documented when an application is made for a marketing authorisation for a hepatitis-B immunoglobulin. The guidance covers biological data, ...

MHRA: Preclinical Assessment of Investigational Cellular and Gene Therapy Products

06.12.2012
The diverse biology and clinical indications and the rapid and fluid state of the evolving scientific research into these product areas pose unique scientific challenges in terms of regulatory ...

EMA: Reflection paper on considerations given to designation of a single stereo isomeric form (enantiomer), a complex, a derivative, or a different salt or ester as new active substance in relation to the relevant reference active substance

29.11.2012
The scope of this paper is restricted to consideration of differences between a single enantiomer, a complex, a derivative or a different salt or ester and the corresponding reference active ...

EMA: Reflection paper on medicinal-product supply shortages caused by manufacturing / good-manufacturing-practice compliance problems

29.11.2012
This Reflection Paper is concerned with public health crises that arise due to unforeseen disruptions within the manufacturing process, caused by manufacturing/GMP compliance problems and ...

GMP: ECA publishes Good Practice Guide on Process Validation

29.11.2012
Since the FDA has revised its \"old\" Validation Guidance in 2011, validation has become a life cycle process with focus on process knowledge and process understanding based on scientific sound ...

MHRA: Public consultation on the revision of European legislation on medical devices

22.11.2012
The MHRA is seeking the views of healthcare professionals, patients, industry, academics, and the interested public on the draft new European legislation on medical devices. In September the ...

FDA: FDA Safety Communication: Updated information on the risks of thrombosis and hemolysis potentially related to administration of intravenous, subcutaneous and intramuscular human immune globulin products

22.11.2012
This update is in follow-up to the FDA Interim Statement Regarding Immune Globulin Intravenous (IGIV), dated August 22, 2002, regarding thrombotic events following IGIV infusion. This Safety ...

EMA: Guideline on the demonstration of palatability of veterinary medicinal products - Draft

22.11.2012
The objective of this guideline is to specify requirements for the design, conduct, and evaluation of palatability studies for all oral dosage forms of pharmaceutical veterinary medicinal products ...