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Posted 12 April 2012 | By Alexander Gaffney
Manufacturers of positron emission tomography (PET) drugs have until 12 June 2012 to comply with new regulations posted by the US Food and Drug Administration (FDA) on 10 April, reports In-Pharma Technologist.
As Regulatory Focus previously reported, FDA has released draft guidance for FDA Oversight of PET Drug Products- Questions and Answers on 27 February, and released final guidance under the same name on 10 April.
While the comment period for that final guidance document ends 29 May, compliance with the guidance must occur by 12 June.
Manufacturers unable to comply with the current good manufacturing practices regulations at that time will be forced to find a new supplier, writes In-Pharma Technologist, which raises the possibility of exacerbating existing drug shortage problems.
The guideline, which covers aseptic manufacturing practices for media fills, should be useful for PET drug manufacturers who needed clarification on the process.
In-Pharma Technologist - FDA posts media fill guidance to help PET drug manufacturers
Regulatory Focus - FDA Releases New Draft Guidance on PET Drug Products
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