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EMA: Draft reflection paper on the data requirements for intravenous iron-based nano-colloidal products developed with reference to an innovator medicinal product

20.09.2013
This reflection paper discusses the data requirements for nano-sized colloidal intravenous iron-based preparations developed as a treatment for iron deficiency with reference to a nano-sized ...

FDA: Investigational New Drug Applications (INDs)-Determining Whether Human Research Studies Can Be Conducted Without an IND

20.09.2013
This guidance is intended to assist clinical investigators, sponsors, sponsor-investigators, and institutional review boards (IRBs) in determining whether research studies involving human subjects ...

FDA: Bioanalytical Method Validation

20.09.2013
This guidance provides assistance to sponsors of investigational new drug applications (INDs), new drug applications (NDAs), abbreviated new drug applications (ANDAs), biologic license ...

FDA: Electronic Source Data in Clinical Investigations

20.09.2013
This guidance provides recommendations to sponsors, Contract Research Organizations (CROs), clinical investigators, and others involved in the capture, review, and retention of electronic source ...

FDA: Patient Counseling Information Section of Labeling for Human Prescription Drug and Biological Products — Content and Format

20.09.2013
This guidance is intended to assist applicants with developing the PATIENT COUNSELING INFORMATION section. The recommendations in this guidance are intended to help ensure that this section of ...

New FDA Regulation gives the Agency more Power during an Inspection

12.09.2013
The U.S. Food and Drug Administration (FDA) is proposing a regulation to implement administrative detention authority during inspections. ...

Specification of the Unique Facility Identifier (UFI) System for Drug Establishment Registration

12.09.2013
This guidance specifies the unique facility identifier (UFI) system for registration of domestic 20 and foreign drug establishments. ...

EXCiPACT - Pilot Phase Successfully Completed!

12.09.2013
EXCiPACTTM is a quality standard for the manufacture, storage and transport of excipients which is now recognised by authorities and the industry worldwide. It has been made available to the ...

New FDA Fees for Drug Master Files published

12.09.2013
The US FDA has published the new fees for 2014. In a Federal Register Statement dated August 2, 2013 the following information has been published: Under the Generic Drug User Fee Act (GDUFA), the ...

GMP: EMA publishes Guideline on Pharmaceutical Development of Medicines for Paediatric Use

05.09.2013
The European Medicines Agency has published the final Guideline on pharmaceutical development of medicines for paediatric use. The date for coming into effect is 15 February 2014. ...