Regulatory

Jan 01, 2016
BioPharm International
Traceability and transparency will remain elusive if manufacturers continue to approach serialization projects on a case-by-case basis.
Dec 10, 2015
By BioPharm International Editors
Changes in China’s Food and Drug Administration (cFDA) drug development and commercialization policies make it easier for multinationals and CMOs to manufacture in China for in-country use, reports CMO and consultant PaizaBio.
Dec 08, 2015
By BioPharm International Editors
FDA approves Kanuma, the first treatment for patients with lysosomal acid lipase.
Dec 07, 2015
While stakeholders generally welcome improvements to quality initiatives, they are concerned with how the new requirements will be implemented for more complicated supply-chain models.
Dec 04, 2015
By BioPharm International Editors
The agency publishes draft guidance on best practices for communication between FDA and IND sponsors during drug development.
Nov 20, 2015
FDA seeks to clarify policies for regulating cellular and tissue-based products.
Nov 19, 2015
Pharmaceutical manufacturers should not be protected from antitrust litigation simply because FTC chooses not to pursue a lawsuit, the agency wrote in a recent amicus brief.
Nov 13, 2015
BioPharm International
Panelists at the meeting will focus on clinical trial design, immunogenicity, and enhancing implementation plans for administering already-licensed vaccines to this patient population.
Nov 03, 2015
The agency holds fast on single billing rules for biosimilars.
Nov 01, 2015
BioPharm International
Virtual pilot programs examine scenarios that may occur while implementing serialization requirements for the US Drug Supply Chain Security Act.
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