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EMA: PRAC recommends further measures to minimise risk of osteonecrosis of the jaw with bisphosphonate medicine

26.03.2015
European Medicines Agency\'s Pharmacovigilance Risk Assessment Committee (PRAC) has completed a periodic review of one of the bisphosphonate medicines with a known risk of osteonecrosis of the ...

EMA: PRAC recommends restrictions on the use of codeine for cough and cold in children

26.03.2015
European Medicines Agency’s Pharmacovigilance Risk Assessment Committee (PRAC) has recommended restrictions on the use of codeine-containing medicines for cough and cold in children because of ...

RAPS: FDA Provides Generic Approval Roadmap for 38 Drugs, Including Vertex\'s Kaldeco

26.03.2015
The US Food and Drug Administration (FDA) has announced the release of new documents meant to make it easier for generic manufacturers to introduce competition to 38 existing drug products, ...

RAPS: UK Regulator Issues First Positive Opinion in Early Access Program

26.03.2015
Merck’s new skin cancer treatment has become the first product approved under a new accelerated review process by the UK’s Medicines and Healthcare Products Regulatory Agency (MHRA). The ...

FDA: Clinical Trial Imaging Endpoint Process Standards

19.03.2015
The purpose of this guidance is to assist sponsors in optimizing the quality of imaging data obtained in clinical trials intended to support approval of drugs and biological products.2 This ...

EMA: Draft guideline on the assessment of the risk to public health from antimicrobial resistance due to the use of an antimicrobial veterinary medicinal product in food-producing animals

19.03.2015
This guideline provides advice in regards to applications for marketing authorisations for antimicrobial veterinary medicinal products on the data required and the methodology to be used for ...

EMA: Draft guideline for the demonstration of efficacy for veterinary medicinal products containing antimicrobial substances

19.03.2015
This guideline provides recommendations for the design and conduct of pre-clinical and clinical studies to support clinical efficacy for an antimicrobial veterinary medicinal product. Appropriate ...

GMP: Causes for Weight Variations during Tableting

19.03.2015
Weight variations of the tablets produced is a relatively common problem of the tableting process. But each tableting process aims at producing tablets with a constant weight. The actual cause for ...

RAPS: EU Task Force to Implement New Drug Identification Standards

19.03.2015
The European Medicines Agency (EMA) has announced it is putting together a task force to oversee the implementation of new standards for identifying drugs. The goal of the task force will be to ...

RAPS: FDA Plans to Fund Research on Generic Drug Efficacy, Medical Countermeasures and More

19.03.2015
The US Food and Drug Administration (FDA) hopes to obtain private sector help to improve nine areas of regulatory science, including the evaluation of generic drug effectiveness and expedited ways ...