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FDA: Draft Guidance for Industry and Food and Drug Administration Staff - Medical Device Reporting for Manufacturers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 The \"Draft Guidance for Industry and Food and ...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

GMP: ASEAN Countries publish Draft of a Guideline on Process Validation

The member states of the Southeast Asian association (ASEAN) have released the draft of a process validation guideline under the management of Singapore. Members of the ASEAN countries are: ...

EMA: Draft policy 70: Publication and access to clinical-trial data

There is growing demand from external stakeholders for full transparency, not only about the European Medicines Agency\'s deliberations and actions, but also about the data and results from ...

EMA: Guidance on format of the risk-management plan in the European Union – in integrated format

This guidance covers the Parts and modules of the RMP which may be required for applications in the EU. ...

EMA: Guidance on triggers for inspections of bioequivalence trials

This document represents a non-exhaustive overview of issues which are taken into account during the assessment phase. Identification of other triggers not mentioned in this document is possible. ...

GMP: EMA Guideline on the use of bovine serum in the manufacture of human biological medicinal products

On 1 December 2013, the adopted Guideline on the use of bovine serum in the manufacture of human biological medicinal products will come into effect. It replaces the Note for Guidance on the use ...

FDA: ANDAs: Stability Testing of Drug Substances and Products, Questions and Answers - Draft Guidance

This draft guidance provides answers to questions from the public comments we received on the draft guidance for industry on ANDAs: Stability Testing of Drug Substances and Products (stability ...

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