Industry News

Dec 07, 2017
An increasing number of warning letters shows that FDA is observing more problems with pharmaceutical contract manufacturing.
Dec 06, 2017
By BioPharm International Editors
A survey by LNS Research and sponsored by Honeywell showed that industrial companies are not moving quickly to adopt cyber security; calls on CEOs to take action.
Dec 05, 2017
By BioPharm International Editors
Biopharma majors are among the industry stakeholders who have commented and raised questions about FDA’s recently proposed draft guidance for analytical assessment of similarity in biosimilars.
Dec 05, 2017
By BioPharm International Editors
During the November meeting of the agency’s Pharmacovigilance Risk Assessment Committee, review of Esmya (ulipristal acetate) was announced as well as warnings about prostate cancer treatments.
Dec 05, 2017
By BioPharm International Editors
The agency and the European Commission published updated guidance to answer questions about Brexit.
Dec 01, 2017
By BioPharm International Editors
In a recently released statement, FDA Commissioner Scott Gottlieb warned of an amino acids supply shortage and gave an update on a saline supply shortage, both due to the impact of hurricanes on Puerto Rican manufacturing facilities.
Nov 30, 2017
Experts slam drug prices and endorse government price negotiations and curbs on drug advertising.
Nov 27, 2017
By BioPharm International Editors
The new guidelines discuss GMPs and patient protection specific to advanced therapy medicinal products.
Nov 27, 2017
Manufacturers and trading partners struggle to meet drug tracking requirements
Nov 21, 2017
By BioPharm International Editors
Following a vote by member states in favor of Amsterdam as the agency’s new headquarters, the relocation will take place over the next 16 months, with operations expected to start up in March 2019.
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