Keyword: Drug Safety

Plant Construction & Process Technology

The EXCiPACT Certification Scheme

27.09.2017 - There is a regulatory expectation that pharmaceutical companies will verify that the excipients produced by their suppliers are to an appropriate level of GMP. This has been...

Plant Construction & Process Technology

The EXCiPACT Certification Scheme

05.10.2014 - Excipients, together with an active pharmaceutical ingredient (API), are formulated into a final drug that is either prescribed to a patient by a doctor or bought over-the-counter...

News

Generic Drugmakers Ramp up Campaign Against FDA Label Plan

03.03.2014 - Generic drugmakers are actively campaigning against a rule proposed by the U.S. Food and Drug Administration (FDA) that would require them to change the prescribing information on...

News

FDA Panel Votes to Relax Avandia Restrictions

07.06.2013 - U.S. health advisers voted on Thursday to recommend relaxing market restrictions on GlaxoSmithKline's diabetes drug Avandia, the former blockbuster at the center of one of the...

News

U.S. Lawmakers Advance Bill on Prescription Drug Tracking

09.05.2013 - A U.S. House of Representatives panel advanced a bill on Wednesday on how the federal government should track prescription drugs as they move through the distribution chain, over...

News

U.S. Launch of Novo's New Insulin Faces Long Delay

01.05.2013 - Denmark's Novo Nordisk could see the U.S. launch of its biggest drug hope, a new long-acting insulin, delayed until 2018 while it conducts more tests to satisfy regulators, it said...

News

Court Stops EU Regulator Releasing Drug Company Data

30.04.2013 - Europe's medicines regulator has been stopped from releasing clinical trial data about drugs made by AbbVie and Intermune, following a court ruling favouring the two U.S. companies...

News

Roche to Release All Tamiflu Drug Data

05.04.2013 - After a lengthy fight, Swiss drugmaker Roche said it had agreed to hand over data from all clinical trials of its best-selling flu drug Tamiflu to a group of outside researchers...