Generics/Biosimilars

Jul 25, 2017
By Pharmaceutical Technology Editors
The agency has published a Q&A guidance document related to self-identification of facilities, review of generic drug submissions, and inspections.
Jul 12, 2017
By Pharmaceutical Technology Editors
The company has entered into a settlement agreement with generic-drug companies to resolve patent litigation.
Jul 05, 2017
By Pharmaceutical Technology Editors
A Supreme Court decision and improvements in analytical processes may speed the biosimilar approval process.
Jun 27, 2017
By Pharmaceutical Technology Editors
The agency announced it is taking steps to increase competition within the prescription drug market.
Jun 23, 2017
By Pharmaceutical Technology Editors
The agency recommended approval of treatments for hepatitis C, cancer, multiple sclerosis, and arthritis.
Jun 21, 2017
By Pharmaceutical Technology Editors
FDA Commissioner Scott Gottlieb announced the agency will hold a public meeting on drug competition as part of its Drug Competition Action Plan.
May 30, 2017
The pharmaceutical industry is making efforts by internally assessing, developing, and implementing semi-continuous manufacturing processes to improve manufacturing efficiencies.
May 16, 2017
By Pharmaceutical Technology Editors
The agency released several new and revised guidance documents regarding product-specific generic drug development.
May 05, 2017
By Pharmaceutical Technology Editors
EMA and the European Commission released a biosimilars information guide for health professionals during the EC’s biosimilars conference.
Apr 13, 2017
Pharmaceutical Technology spoke with CPhI North America presenter Jonathan Helfgott to discuss navigating GDUFA and helpful tips for submitting successful ANDAs.
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