GMP: Authorisation of Generic Drugs in the USA: Requirements on APIs Stability Data for US Drug Master Files

According to the new Generic Drug User Fee Act (GDUFA) for the marketing authorisation of generic drugs in the USA, the Drug Master File (Type II) for APIs must undergo a completeness assessment. ...

FDA: Guidance for Industry Endocrine Disruption Potential of Drugs: Nonclinical Evaluation

This draft guidance provides recommendations to sponsors of investigational new drug applications, new drug applications, and biologics license applications regulated by the Center for Drug ...

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

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

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

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 ...

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