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FDA Releases Final Guidance on PET Drug INDs

FDA has released a final guidance on Investigational New Drug (IND) Applications for Positron Emission Tomography (PET) Drugs that updates a draft released in February with only minor changes. The guidance summarizes the IND process for unapproved PET drugs, makes recommendations on how to submit an IND, provides advice on investigational PET drug access options, […]

The Monthly Update for November is Now Available – A Special Report on the Crisis in Pharmacy Compounding and its Implications

In this Monthly Update, IPQ departs from its usual format encompassing the CMC and GMP developments in the U.S., Europe, and internationally to provide a special report on the causes of the health crisis that has unfolded from fungal contamination in pharmacy compounded injectables and the far-reaching implications that extend across the U.S. drug regulatory arena....

FDA Releases Final Guidance on PET Drug Media Fills; Application Filing Deadline Extended

FDA has finalized a guidance on positron emission tomography (PET) drug media fills that was released as a draft last September and has effectively extended the December 2011 deadline for PET drug application submissions until June....

PET Drug Generator Recall Investigation Points to Hospital User Error

In mid-January, FDA updated healthcare professionals and the public regarding preliminary findings from ongoing investigations following the recall of CardioGen-82 in late July by the manufacturer, Bracco Diagnostics.  The findings point to improper use of the equipment as responsible for some patients receiving excessive radiation exposure. FDA “believes it is unlikely that this excessive exposure […]

Airport Radiation Screening-Induced Recall Highlights PET Drug GMP Challenges; FDA Releases PET Media Fill Guidance

The challenge and importance of GMP management of positron emission tomography (PET) drug processes is underscored by FDA in a new guidance released in October on PET media fills and exemplified by a recent recall of a prominent PET generator...

Year-End Filing Deadline Causing a Flurry of Activity for PET Drug Makers and Regulators

A December 12, 2011 filing deadline for new and abbreviated new drug applications (NDAs/ANDAs) for all positron emission tomography (PET) drugs currently in commercial clinical use is putting heat on manufacturers and FDA to address the outstanding quality regulatory issues for this unique and challenging class of high-tech injectable products....

Recent PET Drug Inspection Findings Shed Light on Upcoming FDA Focal Points

Recent inspection findings at positron emission tomography (PET) drug manufacturing facilities regarding sterility assurance, testing, training and quality oversight provide insight into what FDA investigators will be looking for when inspecting these manufacturers – most for the first time....

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