re: Ann: PGL: Progen Subsidiary Secures New M...
SUDS By way of example below it is clear that the FDA and TGA operate with similar levels of manufacturing compliance.As far as I can determine each identity has all the power depending on where the goods are manufactured eg AUS or USA.The manufacturing requirements are similar however the workings of drugs is another matter.I hope this helps Kens
The United States' Food and Drug Administration (FDA) has issued a 'Warning Letter' to CSL Biotherapies (CSL) following their audit of CSL's manufacturing facility. This is one of 160 similar letters issued to therapeutic goods manufacturers by the FDA this year. Broadly, the issues identified by the FDA are about inadequate documentation and investigation procedures at CSL in relation to CSL's handling of concerns about the quality of its influenza vaccine, Fluvax.
The Therapeutic Goods Administration (TGA) routinely audits CSL as part of its role in regulating therapeutic goods manufacturers and is aware of the issues raised by the FDA. The TGA audits CSL annually and, in addition, has undertaken five separate audits of CSL in the last 12 months following a higher than average rate of adverse reactions in children immunised with CSL's flu vaccine 'Fluvax' in 2010. The most recent audit occurred on 15 and 16 June 2011.
These audits revealed similar issues to those found by the FDA and confirmed that the findings do not relate directly to safety concerns.
Neither the TGA nor the FDA have identified manufacturing deficiencies that would warrant product recall or a change to the vaccine production process.
The TGA is working with CSL and the FDA to resolve the identified deficiencies and to ensure CSL remains fully compliant with manufacturing standards.
The TGA and FDA are collaborating to investigate the possible causes of the adverse reactions in children following immunisation with Fluvax in 2010.
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