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FDA: Completeness Assessments for Type II API DMFs Under GDUFA

17.02.2016
This guidance is intended for holders of Type II active pharmaceutical ingredient (API) drug master files (DMFs) that are or will be referenced in an abbreviated new drug application (ANDA), an ...

GMP: Important Publication of the Delegated Regulation complementing the Anti-Counterfeiting Regulation

17.02.2016
On 9th February 2016 the European Union has published the \"COMMISSION DELEGATED REGULATION (EU) 2016/161 of 2 October 2015 supplementing Directive 2001/83/EC of the European Parliament and of the ...

RAPS: Generic Drug Review Dashboard: FDA Offers a First Look

17.02.2016
As Congress continues to push for the US Food and Drug Administration (FDA) to speed the approval of new generic drugs, which could be key for keeping pharmaceutical prices in check, FDA for the ...

RAPS: EU Regulation Requires New Safety Features on Drug Packaging by 2019

17.02.2016
A new regulation will require prescription drugmakers in all but three EU countries to incorporate new safety features on their product packaging by 9 February 2019. ...

RAPS: Zika: FDA Recommends Deferring At-Risk Blood Donors for Four Weeks

17.02.2016
The US Food and Drug Administration (FDA) is recommending blood banks defer donations from recent travelers to Zika-affected countries. The recommendation comes in the form of a new guidance ...

URPL: Information of President of The Office for Registration of Medicinal Products, Medical Devices and Biocidal Products of February 16, 2015 on the support which European experts will provide in the context of the global response to the growing epidemi

17.02.2016
This document is announcement of President of The Office for Registration of Medicinal Products, Medical Devices and Biocidal Products of February 16, 2015 on the support which European experts ...

URPL: Information of President of The Office for Registration of Medicinal Products, Medical Devices and Biocidal Products of February 16, 2015 on on the malfunctioning analyzer INR used in the study ROCKET

17.02.2016
This document is announcement of President of The Office for Registration of Medicinal Products, Medical Devices and Biocidal Products of February 16, 2015 on on the malfunctioning analyzer INR ...

EMA: Draft concept paper on guidance on statistical principles for clinical trials for immunological veterinary medicinal products

29.01.2016
A guideline on statistical principles for veterinary clinical trials for veterinary medicinal products (pharmaceuticals) (EMA/CVMP/EWP/81976/2010) was adopted in 2012. This guideline provides ...

EMA: First specific replacement therapy to treat rare bleeding disorder

29.01.2016
Coagadex recommended for approval for prevention of bleeding episodes for patients with factor X deficiency The European Medicines Agency (EMA) has recommended granting a marketing authorisation ...

RAPS: FDA Approves First Drug to Improve Overall Survival in Liposarcoma

29.01.2016
FDA Approves First Drug to Improve Overall Survival in Liposarcoma The US Food and Drug Administration (FDA) on Thursday approved a new indication for Eisai\'s Halaven (eribulin mesylate) to ...