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13 June 2019 | By European Pharmaceutical Review
Luxembourg and the Netherlands have been included in the mutual recognition agreement between the EU and the FDA in the US.
10 June 2019 | By European Pharmaceutical Review
A total of 48 US states are now suing Purdue Pharma, claiming they falsely marketed their opioid drug.
4 June 2019 | By European Pharmaceutical Review
Walmart has joined a consortium that’s attempting to build a blockchain for tracking pharmaceutical supply chains.
27 May 2019 | By European Pharmaceutical Review
FDA sends warning to Petra Hygienic Systems Int LTD after they find violations of current good manufacturing practices (cGMPs).
20 May 2019 | By Victoria Rees (European Pharmaceutical Review)
GSK and Novartis found to have misled consumers with the packaging and pricing of their osteoarthritis pain treatment.
14 May 2019 | By Nelson Labs
Nelson Labs has a long history of partnering with pharmaceutical and biopharmaceutical companies. We perform a variety of testing to support your internal quality processes including: sterility (USP 71) testing in a cleanroom for isolator environment, particulates testing (USP 787, 788) using a variety of methods, bacterial endotoxin, filter validations,…
8 May 2019 | By Charles River
Those who work in QC know that the job is more than a box to be checked, and that it can’t be done effectively without confidence in the reported results. Tight timelines, regulatory demands, and stringent data integrity standards can make it hard to focus on what’s really at stake…
Whitepaper: Use of exaggerated surface area to solution volume ratios in extractable studies – equilibrium case
8 May 2019 | By Nelson Labs
This whitepaper serves to illustrate the reasons for exaggerating the extracted surface area to extraction solution volume ratios as is the practice in extractables studies.
2 May 2019 | By European Pharmaceutical Review
Marketing authorisation has been recommended in the EU by an EMA committee for Sixmo (buprenorphine) as a substitution treatment for opioid dependence.
26 April 2019 | By European Pharmaceutical Review
As today’s scientists continue to identify new biopharmaceutical products with potential to treat a wide array of diseases, formulation remains the determining factor in their success. But what is involved in these increasingly complex formulation processes and how do they impact the packaging and delivery systems?
25 April 2019 | By European Pharmaceutical Review
This issue questions whether companies are sufficiently investing in regulatory intelligence software and what the potential consequences of Brexit might be for locations outside of the UK and EU. The issue also features articles on microbiology, formulation and biopharma, courtesy of our in-depth focus sections; as well as outlining the…