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April 15, 2015
This is the first time a single strategy document for both EMA and HMA is presented, reflecting the need for a coordinated approach to address the challenges and opportunities facing the European regulatory system network.
April 14, 2015
The European Medicines Agency releases guidelines for addressing and reporting risks associated with medication errors.
March 30, 2015
The agency outlines recommendations for the development and submission of near infrared analytical procedures.
March 24, 2015
The agency provides guidance on determining the need for environmental assessments for gene therapies, vectored vaccines, and viral and microbial products.
March 23, 2015
Guidance provides labeling standards and an implementation guide for electronic submission of lot distribution reports.
February 20, 2015
The agency is enlisting members of European pharmaceutical associations and industry representatives to participate in IDMP task force.
February 17, 2015
The agency releases five draft guidance documents related to drug compounding and repackaging.
February 06, 2015
The agency releases guidance documents on Individual Patient Expanded Access Applications and disclosing risk information to patients.
February 02, 2015
Biosimilars, supply chain security, quality metrics, and elemental impurities headline guidance topics on FDA’s 2015 agenda.
January 26, 2015
The agency creates an electronic central repository to facilitate drug safety assessment reports.