Standards & Regulations

Apr 06, 2017
The role of patient advocates in shaping regulations and policy has put attention on financial and operational links between drug companies and independent health organizations.
Apr 05, 2017
Scott Gottlieb answers Senators' questions at his confirmation hearing before the Senate Health, Education, Labor and Pensions Committee.
Apr 04, 2017
By BioPharm International Editors
EMA has developed a framework and action plan to foster relationships with the academic community.
Apr 01, 2017
BioPharm International
The complex nature of biologics adds additional CQAs that must be determined to ensure the safe development of biologics
Apr 01, 2017
BioPharm International
Industry fears limited benefits as FDA readies voluntary data tracking program.
Apr 01, 2017
BioPharm International
Susan Schniepp, distinguished fellow at Regulatory Compliance Associates, discusses the value of internal audits and how the information gained can be applied.
Mar 28, 2017
A new report states that wider access to new antivirals for HCV and better screening of patients would help avert 90,000 deaths by 2030.
Mar 28, 2017
By BioPharm International Editors
The agency sent a warning letter to Opto-Pharm Pte Ltd. after deficiencies in sterile manufacturing procedures were found at the company’s Singapore facility.
Mar 27, 2017
Manufacturers and regulators are working to reach consensus on the harmonization of management of postapproval changes.
Mar 24, 2017
By BioPharm International Editors
The agency is recommending the suspension of a variety of medications because of unreliable bioequivalence studies conducted by Micro Therapeutic Research Labs
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