QbD support toned down by FDA in transdermal guidance
The FDA has toned down its support of QbD in final guidance on cutting residual drug in transdermal delivery systems following industry criticism.
Archives for August 29, 2011
update
US Pharma survives hurricane Irene unscathed
Drug manufacturers on the US’ east coast seem to have survived Hurricane Irene unscathed, with only a few incidents of damage reported so far.
vivoPharm branch out in US with MPI partnership and new Hershey office
vivoPharm has extended its oncology offering after striking up an alliance with MPI Research.
Cost-cutting tablet splitting prompts FDA guidance
The rise of tablet splitting has prompted the FDA to advise manufacturers on what data is needed to support applications for scored doses.
Risk-based, centralised trial monitoring wanted by FDA
The FDA is encouraging sponsors to use innovative approaches to lessen reliance on on-site trial monitoring in draft guidance.
OpenClinica ink Athena deal to distribute clinical trial software in China
Open source clinical trial software company OpenClinica has launched a marketing agreement with Athena Healthcare Consultancy to work within the Chinese market.
Costs 'a burden' for API and excipient makers, says BASF after raising prices again
Chemicals giant BASF has increased the price of drug APIs and excipients by 10 per cent for the second time in a year.