GMP: FDA publishes revised Guidance for Applicants of Marketing Authorisations for Generics

The GDUFA (Generic Drug User Fee Act), the new act on fees due for the processing of marketing authorisation applications and the inspection of production sites came into force on 9 July 2012. ...

GMP: EMA gives Clarification to the Variations Guideline in a Q&A Document

The document has integrated the updates made with regard to amendments to the variations and the provisions of the Variations Regulation (EU) No 712/2012. ...

EMA: Draft guideline on the clinical development of medicinal products for the treatment of HIV infection

This guideline replaces EMEA/CPMP/EWP/633/02 Rev 2. It provides guidance on the clinical development of direct-acting antiretrovirals for the treatment of HIV infection. ...

EMA: Draft guideline on clinical investigation of medicinal products in the treatment of hypertension

This is the fouth revision of the guideline on clinical investigation of medicinal products in the treatment of hypertension. The main aim of this revision is to include more comprehensive ...

FDA: Guidance for Industry: ANDA Submissions - Refuse-to-Receive Standards

This guidance is intended to assist sponsors preparing to submit to the Food and Drug Administration (FDA) abbreviated new drug applications (ANDAs) and prior approval supplements (PASs) to ANDAs ...

EMA: Concept paper on the development of a guideline on the demonstration of therapeutic equivalence for locally applied and locally acting products in the gastrointestinal tract

The note for guidance on the clinical requirements for locally applied, locally acting products containing known constituents (CPMP/EWP/239/95) [in the following called ‘guideline’] provides ...

FDA: Draft Guidance with Considerations for the Design of Early-Phase Clinical Trials of Cellular and Gene Therapy Products

Due to the increasing interest and activity in the development of CGT products and because of their potential to address unmet medical needs the FDA published this draft guidance. It is intended ...

EMA: EMA Guideline on Quality of biological active Substances produced by transgene Expression in Animals

In May 2013 the CHMP adopted the Guideline on Quality of biological active substances produced by transgene expression in animals. The date for coming into effect is the 1 December 2013. It will ...

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 ...

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