FDA: Bioanalytical Method Validation

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

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

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

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

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

EXCiPACT - Pilot Phase Successfully Completed!

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

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

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. ...

FDA: Draft Guidance for Industry and Food and Drug Administration Staff - Medical Device Reporting for Manufacturers

Because of the number and complexity of medical devices, FDA\'s Center for Devices and Radiological Health (CDRH) has published many new guidelines. The \"Draft Guidance for Industry and Food and ...

FDA: Guidance for Industry and FDA Staff: - Technical Considerations for Pen, Jet, and Related Injectors Intended for Use with Drugs and Biological Products

This guideline addresses specific application systems with regard to combination products. The guideline deals with aspects relevant for a marketing authorisation and expected by the FDA in a ...

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