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The agency publishes draft guidance on best practices for communication between FDA and IND sponsors during drug development.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.
Oct 29, 2015
BioPharm International
In 2016, Amgen will simultaneously fight off biosimilar competitors to its legacy products and prepare to file its own follow-on products with regulators.
Oct 27, 2015
By BioPharm International Editors
The new committee will attempt to recruit regulatory professionals outside of existing ICH members to improve overall global pharmaceutical regulatory harmonization.
Oct 27, 2015
By BioPharm International Editors
The PRIME program is a drug development scheme to enable accelerated assessment of medications for conditions with unmet need.
Oct 14, 2015
Product labels should include more information on extrapolation, interchangeability, and the original source of clinical trial data, according to a survey of those in charge of dispensing medications.
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