Standards & Regulations

Apr 24, 2017
By BioPharm International Editors
Sandoz has received positive opinions from EMA’s CHMP for its biosimilars rituximab and etanercept for all indications of their respective reference medicines.
Apr 21, 2017
The agency approved Renflexis, a biosimilar to Janssen’s blockbuster rheumatoid arthritis treatment.
Apr 19, 2017
The number of deficiencies found in foreign and UK-based facilities increased in 2016.
Apr 13, 2017
Pharmaceutical Technology spoke with CPhI North America presenter Jonathan Helfgott to discuss navigating GDUFA and helpful tips for submitting successful ANDAs.
Apr 13, 2017
At CPhI North America 2017, the US Pharmacopeial Convention will be discussing its upcoming revision and modernization of the standards for elemental and organic impurities.
Apr 12, 2017
By BioPharm International Editors
The agency cited the company’s India facility for batch failures and data integrity problems.
Apr 12, 2017
By BioPharm International Editors
The new guide offers guidance on how to ensure data and records are complete, consistent, secure, accurate, and available throughout their lifecycle.
Apr 07, 2017
By BioPharm International Editors
The agency released guidance on single assessments of PSURs to improve safety and benefit-risk assessment of medicines.
Apr 06, 2017
A new study in NEJM compares the regulatory review processes of FDA and EMA.
Apr 06, 2017
FDA is in the center of the debate over developing and pricing new cancer therapies.
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