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FDA: Bacterial Vaginosis: Developing Drugs for Treatment

20.07.2016
The purpose of this guidance is to assist sponsors in the overall clinical development program and clinical trial designs to support drugs for the treatment of bacterial vaginosis (BV). This draft ...

RAPS: Federal Circuit: Use of a CMO Prior to Filing Drug Patents Does Not Invalidate the Patents

20.07.2016
Pharmaceutical and biotech companies will likely be relieved to hear that the use of a contract manufacturing organization (CMO) cannot cause a drug’s patents to be invalidated under what’s ...

RAPS: FDA to Drug Compounders: Inspection Changes Coming in August

20.07.2016
The US Food and Drug Administration (FDA) on Tuesday announced major changes with respect to inspections of drug compounders as infections linked to poor quality drugs continue to crop up. ...

RAPS: Generic Drugs From Four Indian and Chinese Companies Blocked From Entering US

20.07.2016
The US Food and Drug Administration (FDA) on Wednesday added four Chinese and Indian companies to a list of generic drug facilities that are banned from shipping products to the US because they ...

RAPS: EMA and FDA Begin Collaborations on Patient Engagement

30.06.2016
The European Medicines Agency (EMA) and the US Food and Drug Administration (FDA) on Wednesday began exchanging more information on the best practices of involving patients in the development, ...

RAPS: FDA Withdraws Document Calling on Biosimilar Developers to Submit 10 Random Suffixes

30.06.2016
The US Food and Drug Administration (FDA) on Tuesday withdrew a document submitted to the Office of Management and Budget (OMB) that offered new details on how biosimilar developers would submit ...

FDA: Early Clinical Trials with Live Biotherapeutic Products: Chemistry, Manufacturing, and Control Information

30.06.2016
This guidance focuses on the chemistry, manufacturing, and control (CMC) information that you should submit in an IND for an LBP. This guidance is applicable to all INDs of LBPs, whether clinical ...

FDA: Elemental Impurities in Drug Products Guidance for Industry

30.06.2016
This draft guidance provides recommendations regarding the control of elemental impurities of human drug products marketed in the United States consistent with implementation of International ...

EMA: Guideline on user safety of topically administered veterinary medicinal products

30.06.2016
Applications for marketing authorisations for veterinary medicinal products (VMPs) in the European Union are issued in accordance with Directive 2001/82/EC as amended by Directive 2004/28/EC and ...

EMA: Improving safety of first-in-human clinical trials

09.06.2016
EMA starts EU-wide reflection on necessary changes to best practices. The European Medicines Agency (EMA) has started a review of the guidelines that describe first-in-human clinical trials and ...