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May 10, 2019
EMA has launched a social media campaign aimed at highlighting how the agency and its network maintain safety and efficacy of medicines available in Europe.
The guidance will assist sponsors in demonstrating a proposed therapeutic protein product is interchangeable with a reference product.
May 09, 2019
The new guidance was issued to assist applicants in determining which abbreviated pathway to take for submitting marketing applications.
The new guidance document discusses reproductive toxicity testing and labeling recommendations.
May 03, 2019
Managing and controlling e-records is vital for maintaining CGMP data integrity.
May 02, 2019
New agency leadership is pressed to promote innovation while addressing safety and quality issues.
We need to understand both sides when it comes to audits, says Siegfried Schmitt, PhD, vice-president, technical, PAREXEL Consulting.
In Karl Fischer analysis, sulfur trioxide can react with DMSO, invalidating test results. The authors evaluated different instruments and methods, described in this article, to minimize the impact on results.
May 01, 2019
The UK’s General Pharmaceutical Council (GPhC) has strengthened its guidance for online pharmacies to further safeguard patients when purchasing medicines.
The CHMP has recommended that Sixmo (buprenorphine) be granted a marketing authorization in the EU as a substitution treatment for opioid dependence.